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Barcode Five Rights System

Use Barcode to prevent medication errors

ADERS ® is a barcode point of care, (BPOC), solution

Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see.... Download Adobe PDF Data Sheet

View a PowerPoint Presentation of ADERS ®.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

FDA Press Releases RSS Feed

Statement on quality issues with certain Cardinal Health surgical gowns and packs
Thu, 16 Jan 2020 15:11:28 EST

Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs

Statement on the Salinas-linked romaine lettuce E. coli O157:H7 outbreak and status update on investigation
Wed, 15 Jan 2020 15:27:40 EST

Romaine outbreaks declared over, investigation advances, root cause analysis continues

Michigan-based food manufacturer agrees to stop production after repeated food safety violations
Mon, 13 Jan 2020 16:28:26 EST

Home Style Foods, Inc., a Michigan-based food manufacturer, has agreed to discontinue selling food products until the company complies with federal regulations and other requirements.

FDA approves first generics of Eliquis
Fri, 10 Jan 2020 15:40:00 EST

The U.S. Food and Drug Administration today approved two applications for first generics of Eliquis (apixaban) tablets.

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review
Fri, 10 Jan 2020 12:47:05 EST

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs
Fri, 10 Jan 2020 12:44:54 EST

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies
Fri, 10 Jan 2020 12:39:16 EST

Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to enhance and modernize the FDA’s approach to medical device safety and innovation
Fri, 10 Jan 2020 12:18:50 EST

The FDA is releasing the Medical Device Safety Action Plan that outlines our vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
Thu, 09 Jan 2020 15:28:21 EST

FDA approved Ayvakit (avapritinib) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation

Trump Administration takes historic steps to lower U.S. prescription drug prices
Thu, 09 Jan 2020 14:28:06 EST

The Trump Administration is taking steps to lower prescription drug prices by proposing a rule that could allow for the importation of certain drugs from Canada and issuing draft guidance explaining how manufacturers could import drugs, biological products originally intended for sale abroad.

FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products
Thu, 09 Jan 2020 11:26:06 EST

FDA, USDA and EPA launch Unified Website for Biotechnology Regulation to streamline information about agriculture biotechnology products.

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
Fri, 03 Jan 2020 17:37:09 EST

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint

FDA approves new treatment for adults with migraine
Mon, 23 Dec 2019 14:26:05 EST

FDA approves Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults.

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
Mon, 23 Dec 2019 11:23:16 EST

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting

FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions
Fri, 20 Dec 2019 15:32:23 EST

The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response
Fri, 20 Dec 2019 15:20:37 EST

FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.

FDA, DEA seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of Operation Vapor Lock
Fri, 20 Dec 2019 12:48:00 EST

The FDA and the Drug Enforcement Administration have seized 44 websites advertising the sale of illicit THC vaping cartridges.

FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence
Thu, 19 Dec 2019 16:03:42 EST

Today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to improve the overall quality of compounded medicines.

Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain
Thu, 19 Dec 2019 11:41:46 EST

National Academies of Sciences, Engineering, and Medicine (NASEM) was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence.

FDA approves new type of therapy to treat advanced urothelial cancer
Wed, 18 Dec 2019 17:26:55 EST

FDA granted accelerated approval to Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4 which is highly expressed in urothelial cancers

Food and Drugs Administration--Recalls/Safety Alerts

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility
Fri, 17 Jan 2020 12:15:40 EST

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.

Yes To Inc. Issues Voluntary Recall of Product Due to Skin Irritation Complaints ‘Grapefruit Vitamin C Glow Boosting Unicorn Paper Mask’
Fri, 17 Jan 2020 08:32:04 EST

Yes To Inc. has issued a voluntary recall of all lots of its Grapefruit Vitamin C Glow-Boosting Unicorn Paper Mask in response to complaints of skin irritation and redness.

Lipari Foods Issues Recall of Various Wedge Deli Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Mon, 13 Jan 2020 17:52:01 EST

Lipari Foods has issued a voluntary recall of various Premo and Fresh Grab wedge sandwiches due to potential contamination of Listeria monocytogenes.

Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Mon, 13 Jan 2020 17:50:14 EST

Lipari Foods has issued a voluntary recall expansion of additional Premo and Fresh Grab sandwiches due to potential contamination of Listeria monocytogenes.

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Mon, 13 Jan 2020 14:39:47 EST

Denton Pharma, Inc. dba Northwind Pharmaceuticals, an affiliate of Northwind Pharmaceuticals, LLC (“Northwind”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300mg, to the consumer level. The recall is in response to the manufacturer’s recall of all un

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles
Fri, 10 Jan 2020 16:35:03 EST

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level.

Stryker Launches Voluntary Field Action for Specific Units of The LIFEPAK® 15 Monitor/Defibrillator
Fri, 10 Jan 2020 15:08:04 EST

Stryker announced today that the company is launching a voluntary field action on specific units of the LIFEPAK 15 monitor/defibrillators.

Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination
Wed, 08 Jan 2020 17:31:20 EST

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.

Fresh Location Announces Product Recall Due to Possible Listeria Contamination
Wed, 08 Jan 2020 16:03:36 EST

Protein Snack Tray 6.44 oz total weight packaged in a 4-compartment plastic tray with UPC: 8-5511000804-6 and with Fresh by lot dates of: 12/21/19, 12/22/19, 12/24/19, 12/27/19, 12/28/19, 12/29/19, 12/31/19, 01/03/20, 01/04/20. Protein Trail Mix 3.52 oz total weight packaged in a 10.5 ounce pla


Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited
Wed, 08 Jan 2020 15:04:32 EST

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse eve

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Tue, 07 Jan 2020 17:25:30 EST

Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA)

Jeni’s Splendid Ice Creams Issues Voluntary Recall of Cold Brew with Coconut Cream
Tue, 07 Jan 2020 08:34:17 EST

Jeni’s Splendid Ice Creams has initiated a voluntary recall of three batches of Cold Brew with Coconut Cream Non-Dairy Frozen Dessert pints because they may contain an undeclared milk allergen

Purely Elizabeth Recalls Pouches of Chocolate Sea Salt Probiotic Granola Recall Due to a Mislabeling Error That Has Resulted in an Undeclared Allergen
Mon, 06 Jan 2020 14:27:54 EST

Purely Elizabeth is initiating a voluntary recall of their Chocolate Sea Salt Probiotic granola due to a mislabeling error that has resulted in an undeclared allergen (walnuts) being present.

Ducktrap River of Maine Recalls One Lot of Herring Center Cuts in Wine Sauce Due to Undeclared Dairy in Product
Sat, 04 Jan 2020 21:26:20 EST

Ducktrap River of Maine of Belfast, Maine is announcing a voluntary recall of Herring Center Cuts in Wine Sauce identified with sell by date Jul 29, 2020 because these products contain undeclared milk due to an incorrect label.

Cargill Voluntarily Recalls 39 One-Pound Bags of Product Packaged as Wilbur Dark Chocolate Covered Cashews Wheat Allergen Presence
Fri, 03 Jan 2020 13:52:58 EST

Cargill is voluntarily recalling 39 one-pound bags of product incorrectly packaged as Wilbur Dark Chocolate Covered Cashews. Sold locally through the Wilbur Chocolate Store in Lititz, Penn., the bags are being recalled out of an abundance of caution because of a wheat allergen presence. Wilbur Dark

Limena, LLC Recalls "Salvadorean String Cheese (Quesillo Cheese)" Because of Possible Health Risk
Fri, 03 Jan 2020 08:03:53 EST

Limena, LLC of Palm Springs, FL. is recalling its 1 lb. (16 ounce) blocks of Salvadorean String Cheese (Quesillo Cheese) semi-soft cheese because it has the potential to be contaminated with Listeria monocytogenes

FiveStar Gourmet Foods Voluntary Recalls Fresh Snack Products Due to Possible Health Risk
Thu, 02 Jan 2020 14:07:19 EST

FiveStar Gourmet Foods takes issues of food safety seriously and in an abundance of caution is voluntarily recalling two fresh produce snack products, MiniMeal2Go-ProteinPack 8.25oz and MiniMeal2Go- AvocadoToast 6.75oz. due to the notification from Almark Foods of Gainesville, GA that Almark Foods m

Dianne's Fine Desserts Issues Allergy Alert on Undeclared Peanut Allergen in Product Sienna Turtle Brownie Item Number 8495241115 Lot Code 19198
Wed, 01 Jan 2020 18:23:00 EST

Dianne's Fine Desserts of Newburyport, MA 01950 is recalling twenty six cases of product Sienna Turtle Brownie 8495241115 lot code 19198 , because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reac

Almark Foods Expanded Recall to all Products from its Georgia Facility Due to Possible Listeria monocytogenes Contamination
Wed, 01 Jan 2020 10:56:48 EST

Almark Foods is expanding its voluntary recall to include all hard-boiled eggs manufactured at the firm’s Gainesville, Georgia facility, including all retail, pillow pack, pouch pack, frozen diced, and protein kit products, , due to potential contamination with Listeria monocytogenes.

Almark Foods Recalls Hard Cooked Egg Products in Pails Due to Possible Listeria Monocytogenes Contamination
Wed, 01 Jan 2020 10:54:30 EST

Almark Foods is voluntary recalling Hard-Boiled and Peeled Eggs in white plastic pails with white plastic lids due to the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or

What's New: Drugs RSS Feed

What's New Related to Drugs
Fri, 17 Jan 2020 17:42:56 EST

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

FDA Voices: Perspectives From FDA Leadership and Experts
Fri, 17 Jan 2020 14:53:23 EST

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

Applications Affected by the Reorganization of the Office of New Drugs
Fri, 17 Jan 2020 13:51:36 EST

The approved restructuring of the Office of New Drugs (OND) creates offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise.

FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development
Fri, 17 Jan 2020 13:17:20 EST

Announcing an Orphan Drug Technology Modernization effort and the 2020 FDA Rare Disease Day meeting, this article discusses upcoming FDA activities to support medical product development for rare diseases.

FDA Voices on Medical Products
Fri, 17 Jan 2020 13:12:27 EST

FDA Voices on Medical Products

Compounding: Inspections, Recalls, and other Actions
Fri, 17 Jan 2020 12:40:45 EST

Human drug compounding; FDA inspections; compounding recalls

Advancing Animal Models for Antibacterial Drug Development - 03/05/2020 - 03/05/2020
Fri, 17 Jan 2020 12:31:03 EST

The purpose of the public workshop is to discuss progress and challenges in the development and advancement of various animal models for serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility
Fri, 17 Jan 2020 12:15:40 EST

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry, to the user level, due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines.

Drug Shortages | Additional News and Information
Fri, 17 Jan 2020 11:49:58 EST

Drug Shortages: Additional News and Information

Gastrointestinal Drugs Advisory Committee Roster
Fri, 17 Jan 2020 11:41:17 EST

This page contains the Gastrointestinal roster, which lists the current members and the current number of vacancies for the committee.

Drug Shortages: Non-Compliance With Notification Requirement
Fri, 17 Jan 2020 11:15:46 EST

Drug Shortages: Non-Compliance With Notification Requirement

Phonetic and Orthographic Computer Analysis (POCA) Program
Fri, 17 Jan 2020 10:59:27 EST

Use CDER’s Phonetic and Orthographic Computer Analysis (POCA) to help identify drug and biologic names that are phonetically and/or orthographically similar to one another. In conducting proprietary name reviews, the Division of Medication Error Prevention and Analysis (DMEPA) evaluates the orthographic and phonetic similarity of a proposed proprietary name to other proprietary or established names using the POCA software program. POCA uses algorithms to assess the similarity of names when spoken or written and assigns a percent similarity score to a given name pair.

Treating and Preventing Head Lice
Fri, 17 Jan 2020 08:44:40 EST

Head lice. Learn how to check for them, how to treat them, and how to avoid having them in your home.

Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment
Fri, 17 Jan 2020 08:41:14 EST

Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Thu, 16 Jan 2020 18:26:11 EST

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
Thu, 16 Jan 2020 11:11:07 EST

FDA alerts health care professionals and patients to voluntary recall of ranitidine medicines

How to Report a Shortage or Supply Issue
Thu, 16 Jan 2020 08:52:13 EST

How to Report a Shortage or Supply Issue

Identification of Concepts and Terminology for Multi-Component Biomarkers Workshop - 03/23/2020 - 03/23/2020
Wed, 15 Jan 2020 14:01:50 EST

A productive discussion on the development of a conceptual, hierarchical & specific set of terminology needs in the biomarker domain.

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 02/19/2020 - 02/19/2020
Wed, 15 Jan 2020 13:49:08 EST

The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by CDER and CBER

Office of Generic Drugs: Offices and Divisions
Wed, 15 Jan 2020 11:35:09 EST

Generic Drugs Offices and Divisions

Whats New Vaccines Blood Biologics RSS Feed

FDA Voices: Perspectives From FDA Leadership and Experts
Fri, 17 Jan 2020 14:53:23 EST

Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement.

FDA Harnesses Technology and Collaboration to Support Rare Disease Product Development
Fri, 17 Jan 2020 13:17:20 EST

Announcing an Orphan Drug Technology Modernization effort and the 2020 FDA Rare Disease Day meeting, this article discusses upcoming FDA activities to support medical product development for rare diseases.

FDA Voices on Medical Products
Fri, 17 Jan 2020 13:12:27 EST

FDA Voices on Medical Products

Cleared 510(k) Submissions with Supporting Documents - 2019
Fri, 17 Jan 2020 10:40:33 EST

List of Cleared 510(k) Submissions with Supporting Documents for 2019

Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement - 03/04/2020 - 03/04/2020
Fri, 17 Jan 2020 09:57:41 EST

This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee March 4, 2020 Meeting Announcement.

What’s New for Biologics
Fri, 17 Jan 2020 09:37:52 EST

Latest news from the Center for Biologics Evaluation and Research

Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Fri, 17 Jan 2020 09:14:51 EST

These are the Meeting Materials for the Vaccines and Related Biological Products Advisory Committee

2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
Fri, 17 Jan 2020 09:14:36 EST

This is the main page for the CBER 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee.

Fractionated Plasma Products
Fri, 17 Jan 2020 06:42:27 EST

Listing of fractionated plasma products

Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Thu, 16 Jan 2020 18:26:11 EST

Draft Guidance for Industry: Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products

Biologics PREA Reviews and Labeling Changes
Thu, 16 Jan 2020 15:02:58 EST

PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act.

Fast Track Designation Request Performance
Thu, 16 Jan 2020 11:42:43 EST

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling submission" for a marketing application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

Vaccines Licensed for Use in the United States
Thu, 16 Jan 2020 10:30:35 EST

The product name and trade name of vaccines licensed for use in the United States.

Roster of the Cellular, Tissue and Gene Therapies Advisory Committee
Wed, 15 Jan 2020 09:43:50 EST

This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers
Wed, 15 Jan 2020 09:40:08 EST

Draft guidance for industry: Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers

ADVIA Centaur HIV 1/O/2 Enhanced ReadyPack Reagents
Tue, 14 Jan 2020 14:16:22 EST

For qualitative determination of antibodies to the human immunodeficiency virus type 1, including Group O, and/or type 2 in serum or plasma

Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act
Tue, 14 Jan 2020 10:43:20 EST

Guidance for Industry: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

Section 8100: Communication
Tue, 14 Jan 2020 10:10:22 EST

This is the CBER SOPP Section 8100: Communication main page.

BioCompute Objects: Tools for Communicating NGS Data and Analysis; Public Workshop - 05/14/2019 - 05/15/2019
Tue, 14 Jan 2020 09:01:15 EST

The Food and Drug Administration (FDA), the George Washington University and the BioCompute Partnership are co-sponsoring a workshop entitled, “BioCompute Objects: Tools for Communicating Next Generation Sequencing Data and Analysis.”

Flucelvax Quadrivalent
Tue, 14 Jan 2020 07:59:53 EST

For active immunization of children and adolescents 4 years of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.


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