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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

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process
Fri, 14 Feb 2020 16:44:00 EST

FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad
Fri, 14 Feb 2020 16:31:48 EST

FDA is an active partner in the COVID-19 response, working closely with government and public health partners across HHS and international counterparts.

FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
Fri, 07 Feb 2020 13:43:50 EST

FDA analysis published today advances the understanding of intentional genomic alterations in animals.

FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User
Fri, 07 Feb 2020 13:37:15 EST

Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images.

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic
Wed, 05 Feb 2020 17:08:50 EST

Today, FDA issued an EUA to enable emergency use of CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows use of the test at any CDC-qualified lab across the country.

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures
Tue, 04 Feb 2020 11:03:00 EST

FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

FDA approves first drug for treatment of peanut allergy for children
Mon, 03 Feb 2020 16:24:13 EST

FDA approves first drug for treatment of peanut allergy for children
Treatment with this product may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older.

FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans
Mon, 03 Feb 2020 12:07:16 EST

The U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products.

FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data
Wed, 29 Jan 2020 14:35:54 EST

FDA launches an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.

FDA Continues Strong Support of Innovation in Development of Gene Therapy Products
Tue, 28 Jan 2020 08:29:24 EST

FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
Thu, 23 Jan 2020 17:59:32 EST

FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection

FDA informs health care providers, facilities and patients about potential cybersecurity vulnerabilities for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers
Thu, 23 Jan 2020 14:13:13 EST

FDA is issuing a safety communication informing health care providers, facilities and patients about cybersecurity vulnerabilities identified for certain GE Healthcare Clinical Information Central Stations and Telemetry Servers.

FDA approves first treatment for thyroid eye disease
Tue, 21 Jan 2020 14:40:39 EST

FDA approved Tepezza for the treatment of adults with thyroid eye disease. Today’s approval represents the first drug approved for the treatment of thyroid eye disease.

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.

Food and Drugs Administration--Recalls/Safety Alerts

CJ Foods Voluntarily Recalls Annie Chun’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts
Fri, 14 Feb 2020 00:00:00 EST

CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. Use of this product may cause serious allergic reaction or illness in people who have an allergy or severe sensitivit

Gourmet International and Butlers Chocolates Issue Allergy Alert on Undeclared Milk in Butlers Irish Whiskey Dark Chocolate 3.5 oz Tablet Bar
Thu, 13 Feb 2020 16:03:00 EST

Are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction or illness if they consume these products.

Save A Lot Issues Allergy Alert on Undeclared Peanuts in Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice-Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers
Thu, 13 Feb 2020 00:00:00 EST

Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquar

Voluntary Recall Notice of Sunny Select Au Jus Gravy Mix 1 oz Pouches Due to Unlabeled Dairy Allergen
Tue, 11 Feb 2020 11:49:00 EST

McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen.

Lotte Int’l America Corp Issues Allergy Alert on Undeclared Almonds in Chocopies
Tue, 11 Feb 2020 00:00:00 EST

Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”.

Blendtopia Products, LLC Voluntarily Recalls Frozen Smoothie Products Due to Possible Health Risk
Mon, 10 Feb 2020 20:03:00 EST

Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand superfood Smoothie Kits because of potential contamination with Listeria monocytogenes.

Missa Bay LLC Issues Allergy Alert and Recall on Mislabeled Salad Product
Mon, 10 Feb 2020 19:45:00 EST

Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the pac

Corinthian Foods Recall 5 Lb Bags of Uncooked Sweet Potato Crusted Alaska Nuggets 1 Oz. Due to Mislabeling
Sat, 08 Feb 2020 19:00:00 EST

Corinthian Trading, Inc./DBA Corinthian Foods is recalling 5 lb. retail bags of Uncooked Sweet Potato Crusted Alaska Pollack Nuggets 1 oz. with date code CF35319 due to mislabeling. The bag contains Chicken Nuggets instead of Fish Nuggets. The product is packaged in clear 5 lb. bags with a white

Nuts ‘N More LLC. Recalls: Plain Peanut Spread Because Of Possible Health Risk
Fri, 07 Feb 2020 00:00:00 EST

Nuts ‘N More of East Providence, RI. is recalling 4143 jars of plain Peanut Spread because it has the potential to be contaminated with Listeria species and to protect the public from a potential health hazard.

New Seasons Market Recalls Grab N’ Go Vegetarian Lasagna w/Gluten Free Pasta Due to Undeclared Soy
Thu, 06 Feb 2020 00:00:00 EST

This product is being voluntarily recalled due to the presence of an undeclared allergen (soy). Customers who purchased this product and are allergic to soy are urged to not consume it.

Cargill Conducts Voluntary Recall of a Single Lot of Nutrebeef® Transition Pellet Due to Elevated Levels of Monesin
Tue, 04 Feb 2020 15:37:00 EST

Cargill’s animal nutrition business is conducting a voluntary recall of a single lot (382 bags, 50 lb each) of NutreBeef® Transition Pellet (MH) beef cattle feed because the product may contain mispackaged feed with elevated levels of monensin

Allergy Alert Issued for Undeclared Milk in Bundt Cake and Chocolate Dipped Cookies Sold at 44 Whole Foods Market Stores in the Mid-Atlantic Region
Tue, 04 Feb 2020 00:00:00 EST

Whole Foods Market is voluntarily recalling select bundt cakes and chocolate dipped cookies from stores in Kentucky, Maryland, New Jersey, Pennsylvania, Ohio, Virginia and Washington D.C. because they contain undeclared milk.
People who have an allergy or severe sensitivity to milk run the risk of

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination
Fri, 31 Jan 2020 00:00:00 EST

Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk (Updated Lot Number Information)
Fri, 31 Jan 2020 00:00:00 EST

Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination in one of the ingredients used on the formula of Nopalina Flax Seed Fiber.

Bakkavor Foods USA, Inc. Issues Allergy Alert on Undeclared Milk in Mushroom Barley Soup
Wed, 29 Jan 2020 10:01:00 EST

Bakkavor Foods USA, Inc. is voluntarily recalling 840 units of Harris Teeter’s Fresh Food Market Mushroom Barley Soup, 16 oz with “SELL BY” date codes 03/09/20 because it may contain undeclared milk.

Beepa’s Issues Allergy Alert in Undeclared Milk in Product
Wed, 29 Jan 2020 00:00:00 EST

Beepa’s of Beloit, WI is recalling Goulash, because it may contain undeclared milk

Salud Natural Entrepreneur Inc. Recalls Nopalina Flax Seed Fiber Powder and Nopalina Flax Seed Fiber Capsules Because of Possible Health Risk
Tue, 28 Jan 2020 00:00:00 EST

Salud Natural Entrepreneur, Inc. of Waukegan, IL is voluntarily recalling Nopalina Flax Seed Fiber (powder) and Nopalina Flax Seed Fiber (capsule) products due to possible Salmonella contamination

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2
Fri, 24 Jan 2020 15:30:00 EST

King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub

Quesos La Ricura LTD. Recalls Cotija Cheese (Queso Cotija) Because Of Possible Health Risk
Fri, 24 Jan 2020 00:00:00 EST

Quesos La Ricura LTD. of Hicksville, NY, is recalling 12 oz. packages of Cotija Cheese (Queso Cotija) because it may be contaminated with Shiga toxin producing E. coli bacteria (Shiga toxin producing E. coli).

Lipari Foods Issues Voluntary Recall Expansion on Additional Sandwiches Due to Potential Contamination of Listeria Monocytogenes
Wed, 22 Jan 2020 16:46:00 EST

Lipari Foods is expanding its January 6, 2020 and January 13, 2020 recalls of Premo and Fresh Grab sandwiches to include all sandwiches with a Best By date of 2/6/20 and prior, due to potential contamination of Listeria monocytogenes

What's New: Drugs RSS Feed

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Fri, 14 Feb 2020 17:07:51 EST

Guidance for Industry - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers

How FDA Plans to Help Consumers Capitalize on Advances in Science
Fri, 14 Feb 2020 14:35:11 EST

How FDA Plans to Help Consumers Capitalize on Advances in Science

Peripheral and Central Nervous System Drugs Advisory Committee Roster
Fri, 14 Feb 2020 14:23:00 EST

This page contains the Peripheral and Central Nervous System Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee

What's New Related to Drugs
Fri, 14 Feb 2020 13:55:29 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 Working to Lift Barriers to Generic Drug Competition
Fri, 14 Feb 2020 13:20:29 EST

FDA Working to Lift Barriers to Generic Drug Competition

FDA Widens Scope of Navigator – Information Tool for Expanded Access
Fri, 14 Feb 2020 13:18:50 EST

FDA Widens Scope of Navigator – Information Tool for Expanded Access

FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United States
Fri, 14 Feb 2020 13:17:02 EST

FDA is Using Innovative Methods to Prevent Illegal Products with Hidden Drug Ingredients from Entering the United States

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options
Fri, 14 Feb 2020 13:11:38 EST

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options

Biomarker Qualification Submissions
Fri, 14 Feb 2020 13:10:35 EST

The FDA CDER Biomarker Qualification Program invites submitters who have a biomarker qualification project accepted into the Program to voluntarily provide general information about their project and contact information to be posted on the FDA’s public web site. The table below lists submissions that are currently in the qualification process. Submissions listed here are only for those which submitters have agreed to make public. The table is updated on a quarterly basis and provides information on the biomarker qualification project and submitter contact information.

FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse
Fri, 14 Feb 2020 12:52:04 EST

FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse

FDA and Partners Working to Prevent Surgical Fires
Fri, 14 Feb 2020 12:36:20 EST

The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error - the surgical fire.

FDA 101: How to Use the Consumer Complaint System and MedWatch
Fri, 14 Feb 2020 12:29:32 EST

Advice on using FDA's Consumer Complaint System and MedWatch.

Fact or Fiction: What to Know About Smoking Cessation and Medications
Fri, 14 Feb 2020 12:24:31 EST

Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. Learn the facts.

FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation
Fri, 14 Feb 2020 12:13:28 EST

FDA’s Comprehensive Effort to Advance New Innovations: Initiatives to Modernize for Innovation

APS BioGroup, Inc - 04/05/2018
Fri, 14 Feb 2020 11:24:51 EST

Unapproved New Drugs/Misbranded

Caution: Some Over-the-Counter Medicines May Affect Your Driving
Fri, 14 Feb 2020 11:15:24 EST

Antihistamines and other OTC drugs can impair your ability to drive and operate machinery.

Benzocaine and Babies: Not a Good Mix
Fri, 14 Feb 2020 11:13:07 EST

Parents should avoid using benzocaine products to relieve teething pain for children under 2. They are at risk for the disease methemoglobinemia.

Data Standards Program Strategic Plan and Board
Fri, 14 Feb 2020 10:59:37 EST

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

CDER Data Standards Program
Fri, 14 Feb 2020 10:55:55 EST

CDER Data Standards Program

Generic Drugs Program Activities Report - Monthly Performance
Fri, 14 Feb 2020 10:41:06 EST

This report provides monthly activities metrics for the FDA Generic Drugs Program, outlining agency actions on abbreviated new drug applications. Data includes approvals, applications received, complete responses, and more.

Whats New Vaccines Blood Biologics RSS Feed

What’s New for Biologics
Fri, 14 Feb 2020 18:22:42 EST

Latest news from the Center for Biologics Evaluation and Research

Direct Recall Classification Program
Fri, 14 Feb 2020 18:00:42 EST

CBER's Direct Recall Classification (DRC) program provides establishments the opportunity to electronically report recall related information directly to CBER.

Electronic Submission of Biological Product Deviation Reports (eBPDR)
Fri, 14 Feb 2020 17:32:24 EST

Biological Product Deviation Reports can now be submitted electronically via the internet.

How FDA is Putting the Patient Voice at the Forefront of Gene Therapy Clinical Trials for Hemophilia
Fri, 14 Feb 2020 17:29:10 EST

FDA is Putting the Patient Voice at the Forefront of Gene Therapy Clinical Trials for Hemophilia through Rare Disease Patient Listening Sessions.

Instructions for Using the eBPDR System
Fri, 14 Feb 2020 17:18:32 EST

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

General Instructions for Completing the Biological Product Deviation Report (BPDR) - Form FDA 3486
Fri, 14 Feb 2020 17:16:23 EST

For use by biological product manufacturers to report biological product deviations (BPD) that may affect the safety, purity, or potency of a distributed product in accordance with 21 CFR, Part 600.14 or 606.171. Also for use by Human Cells, Tissues and Cellular and Tissue-Based Product (HCT/P) manufacturers to report HCT/P deviations in accordance with 21 CFR 1271.350(b).

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Fri, 14 Feb 2020 17:07:51 EST

Guidance for Industry - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers

Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)
Fri, 14 Feb 2020 15:34:32 EST

Guidance for Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs), CBER, Biologics

Cellular & Gene Therapy Guidances
Fri, 14 Feb 2020 14:58:18 EST

This page contains a listing of cellular and gene therapy guidances.

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options
Fri, 14 Feb 2020 13:11:38 EST

FDA Taking New Steps to Better Inform Physicians about Biosimilars Through Education about these Potentially Cost-Saving Options

FDA 101: Regulating Biological Products
Fri, 14 Feb 2020 12:32:25 EST

Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies.

FDA 101: How to Use the Consumer Complaint System and MedWatch
Fri, 14 Feb 2020 12:29:32 EST

Advice on using FDA's Consumer Complaint System and MedWatch.

FDA’s New Efforts to Advance Biotechnology Innovation
Fri, 14 Feb 2020 12:15:30 EST

FDA’s New Efforts to Advance Biotechnology Innovation

Facilitating End-to-End Development of Individualized Therapeutics - 03/03/2020 - 03/03/2020
Fri, 14 Feb 2020 12:03:23 EST

The purpose of the CBER Individualized Therapeutics public workshop is to foster development of individualized therapeutic products for the treatment of one individual or a very small number of patients, based on engineering a product aimed at the specific molecular mechanism underlying a patient’s (or small group of patients’) illness

Biologics Guidances
Fri, 14 Feb 2020 09:59:05 EST

This page displays links to Biologics Guidance documents.

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2020
Fri, 14 Feb 2020 09:55:22 EST

This is the list of guidance topics CBER is considering for development during Calendar Year 2020.

Vaccines Licensed for Use in the United States
Fri, 14 Feb 2020 06:52:16 EST

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

Informed Consent
Thu, 13 Feb 2020 14:36:00 EST

Informed Consent Information Sheet - Draft Guidance

FDA Budget Matters: Investing in Advanced Domestic Manufacturing
Thu, 13 Feb 2020 13:07:36 EST

FDA Budget Matters: Investing in Advanced Domestic Manufacturing

FDA Budget Matters: A Cross-Cutting Data Enterprise for Real World Evidence
Thu, 13 Feb 2020 13:05:08 EST

FDA Budget Matters: A Cross-Cutting Data Enterprise for Real World Evidence


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