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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 continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths
Fri, 20 Sep 2019 11:45:27 EDT

Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths

FDA approves first oral GLP-1 treatment for type 2 diabetes
Fri, 20 Sep 2019 10:18:18 EDT

FDA approves Rybelsus (semaglutide) oral tablets to improve blood sugar in adults with type 2 diabetes, with diet and exercise. It is first GLP-1 receptor protein treatment approved in U.S.

FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products
Fri, 20 Sep 2019 10:05:21 EDT

FDA issues proposed rule for premarket tobacco product applications as part of commitment to continuing strong oversight of e-cigarettes and other tobacco products

FDA recommends health care facilities and manufacturers begin transitioning to duodenoscopes with disposable components to reduce risk of patient infection
Fri, 20 Sep 2019 09:36:56 EDT

FDA recommends duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety.

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death
Thu, 19 Sep 2019 22:01:00 EDT

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s ongoing commitment to improving efficiency, transparency of tobacco product application review process as part of FDA’s comprehensive framework to reduce tobacco-related disease and death.

FDA continues to take steps to fulfill its commitment to strengthen and modernize the 510(k) medical device program
Thu, 19 Sep 2019 11:13:00 EDT

FDA is issuing draft guidances outlining recommended premarket performance criteria and testing methodologies for four specific types of devices under the Safety and Performance Based Pathway for medical devices.

Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products
Wed, 18 Sep 2019 15:51:13 EDT

: FDA intends to finalize compliance policy that would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes, clearing the market these products.

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions
Wed, 18 Sep 2019 11:26:02 EDT

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
Tue, 17 Sep 2019 12:51:44 EDT

FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
Tue, 17 Sep 2019 11:37:37 EDT

Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, Australia and Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
Fri, 13 Sep 2019 16:52:35 EDT

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

FDA proposes new required health warnings with color images for cigarette packages and advertisements to promote greater public understanding of negative health consequences of smoking
Wed, 11 Sep 2019 01:37:03 EDT

FDA has issued a proposed rule to require new health warnings on cigarette packages and in ads to promote greater public understanding of the negative health consequences of smoking.

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations
Wed, 11 Sep 2019 01:37:00 EDT

The FDA posted a warning letter for significant current good manufacturing practice violations, including data integrity issues.

FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery
Wed, 11 Sep 2019 01:36:53 EDT

FDA expands indication for several transcatheter heart valves to patients at low risk for death or major complications associated with open-heart surgery.

FDA approves new antibiotic to treat community-acquired bacterial pneumonia
Wed, 11 Sep 2019 01:36:50 EDT

The FDA approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety
Wed, 11 Sep 2019 01:36:07 EDT

FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved cannabidiol products online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

FDA approves first therapy for rare joint tumor
Wed, 11 Sep 2019 01:35:53 EDT

FDA approves first therapy for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)

Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings
Wed, 11 Sep 2019 01:35:50 EDT

A new study in the American Journal of Preventive Medicine highlights the continued success and impact the FDA’s “The Real Cost” campaign has had on youth smoking initiation.

FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign
Wed, 11 Sep 2019 01:35:47 EDT

FDA is launching its first youth e-cigarette prevention TV ads and is planning to provide new educational resources as agency approaches one-year anniversary of public education campaign.

FDA statement on court ruling related to compounded bulk drug substances and the agency’s ongoing efforts to implement its compounding authorities
Wed, 11 Sep 2019 01:35:33 EDT

A U.S. District Court judge in Washington, D.C. issued a decision that upheld FDA’s interpretation of clinical need regarding the bulk substances that may be used by outsourcing facilities in drug compounding.

Food and Drugs Administration--Recalls/Safety Alerts

Roland Foods, LLC Initiates a Voluntary Recall of Roland Red Lumpfish Caviar and Roland Black Lumpfish Caviar Due to Possible Health Risk
Fri, 20 Sep 2019 21:34:57 EDT

Roland Foods, LLC of New York, New York is initiating a voluntary recall of its red and black lumpfish caviar products, which were manufactured at Ora ehf in Iceland, because they have the potential to be contaminated with Clostridium botulinum.

Ridley Block Operations Voluntarily Recalls a Batch of Ultralyx 2416-5 No Other Products are Affected; Distribution was Limited to Georgia and Florida
Fri, 20 Sep 2019 11:04:16 EDT

Ridley Block Operations is voluntarily recalling one batch of Ultralyx 24-165. The product has been found to be out of specification, with elevated levels of non-protein nitrogen (NPN). The affected product could have adverse health effects on cattle.

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
Fri, 20 Sep 2019 07:03:55 EDT

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity.

Abbott Laboratories Recalls Calcilo XD® Infant Formula
Wed, 18 Sep 2019 18:51:07 EDT

Out of an abundance of caution, Abbott has voluntarily recalled a single lot of Calcilo XD® powder cans (13.2oz / 375g) with lot number 79696K80 in the United States and Canada due to an inconsistency in aroma and color in a small number of cans from this specific batch.

Southeastern Grocers Issues Voluntary Recall Variety pack cookie products sold in Southeastern Grocers stores
Wed, 18 Sep 2019 17:18:24 EDT

Southeastern Grocers (SEG), the parent company of BI-LO, Fresco y Más, Harveys Supermarkets and Winn-Dixie stores, is issuing a voluntary recall for two 18-count cookie products sold in the bakery. The recall is due to the inclusion of an undeclared allergen in the products.

SCHWARTZ BROTHERS BAKERY ISSUES ALLERGY ALERT ON UNDECLARED EGG IN LEMON DESSERT BARS
Wed, 18 Sep 2019 16:09:00 EDT

Schwartz Brothers Bakery of Seattle, WA is recalling 24 units of Lemon Dessert Bars, sell by date 09/21/19, because it may contain undeclared Egg. People who have an allergy or severe sensitivity to Egg run the risk of serious or life-threatening allergic reaction if they consume these products.

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil
Mon, 16 Sep 2019 18:35:41 EDT

Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved

General Mills Recalls Five Pound Bags of Gold Medal Unbleached All Purpose Flour
Mon, 16 Sep 2019 18:06:01 EDT

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020.

Takeda Issues US Recall of NATPARA® (parathyroid hormone) for Injection Due to the Potential for Rubber Particulate
Mon, 16 Sep 2019 09:10:09 EDT

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company is issuing a US recall for all doses of NATPARA® (parathyroid hormone) for Injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg). This recall is being conducted after discussions with the FDA and is effec

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error
Fri, 13 Sep 2019 21:40:24 EDT

Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A, of Quinacrine Dihydrochloride, bulk API powder packaged in Amber HDPE Bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quin

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
Fri, 13 Sep 2019 12:20:28 EDT

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility.

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
Fri, 13 Sep 2019 12:11:24 EDT

KRS Global Biotechnology, Inc. is voluntarily recalling all lots of unexpired human and animal drugs intended to be sterile to the consumer level. The products are being recalled due to lack of assurance of sterility.

Urban Remedy Voluntarily Recalls 76 Salads, Wraps That May Contain E.Coli Bacteria No Illnesses Reported, Company Taking Preventive Action
Fri, 13 Sep 2019 10:20:48 EDT

Urban Remedy, a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 76 salads and wraps that contain spinach that may be contaminated with E. coli. Seventy-six salads and wraps are still unaccounted for. No juices or any other products are being recalled.

Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Nougat Candies
Thu, 12 Sep 2019 14:21:33 EDT

RONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Nougat candy because they may contain undeclared eggs and milk allergens

Rong Shing Issues Allergy Alert on Undeclared Eggs and Milk in FuPaiYuan Matcha Candies
Thu, 12 Sep 2019 13:57:58 EDT

RONG SHING of Brooklyn, NY is recalling its 450g packages of FuPaiYuan Matcha candy because they may contain undeclared eggs and milk allergens

Stark Group International Issues Allergy Alert on Undeclared Milk Allergens in Ritter Sport KAFFEESPLITTER - 3.5 Ounce /100 Gram
Thu, 12 Sep 2019 11:52:44 EDT

Stark Group International of Greenvale, NY is recalling all codes of its 100 gram packages of Ritter Sport -KAFFEESPLITTER because they may contain undeclared milk allergens.

House Of Spices (India) Issues Recall of "MDH Sambar Masala" Due To Salmonella Contamination
Wed, 11 Sep 2019 15:10:08 EDT

House of Spices (India) is recalling different lots of “MDH SAMBAR MASALA”, 3.5oz (100g) UPC code 6291103750327.This product is produced by R-PURE AGRO SPECIALITIES and distributed by HOUSE OF SPICES (INDIA). This product was tested by FDA through a certified laboratory to be positive for Salmonella

Recall of Yellowfin Tuna Steaks Issued
Wed, 11 Sep 2019 14:36:14 EDT

On September 6, 2019, Alfa International Seafood, Inc. of Medley, FL, voluntarily initiated a recall of refrigerated, wild-caught yellowfin tuna loins because of potentially elevated levels of histamine.

Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance
Wed, 11 Sep 2019 13:37:08 EDT

Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot.

Hy-Vee Voluntarily Recalls Several Hy-Vee Mealtime Asian Entrees Due to Undeclared Milk Allergen
Wed, 11 Sep 2019 11:37:10 EDT

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling seven of its Hy-Vee Mealtime Asian Entrees after discovering the liquid egg used to make the fried rice contains milk, which is not declared on the product label.

What's New: Drugs RSS Feed

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)
Fri, 20 Sep 2019 16:22:00 EDT

Get updates on the recalls

Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan
Fri, 20 Sep 2019 16:15:04 EDT

Find out which specific blood pressure medications are affected by the recall

What's New Related to Drugs
Fri, 20 Sep 2019 14:36:55 EDT

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.

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
Fri, 20 Sep 2019 14:35:46 EDT

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Draft Guidance, Level 1, CBER, CDER Biologics, Drugs, September 2019

Tainted Sexual Enhancement Products
Fri, 20 Sep 2019 13:23:17 EDT

Sexual enhancement products sold over the counter may contain hidden drugs that could be harmful. Buyers should use caution. There is a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are usually promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making
Fri, 20 Sep 2019 13:23:03 EDT

Under the FDA Reauthorization Act of 2017, FDA agreed, in accordance with section I of the PDUFA VI Performance Goals, Ensuring the Effectiveness of the Human Drug Review, part J, Enhancing Regulatory Decision Tools to Support Drug Development and Review, to convene a series of workshops to identify

Public Notification: Green Lumber contains hidden drug ingredient
Fri, 20 Sep 2019 13:17:14 EDT

[9-19-2019] The Food and Drug Administration is advising consumers not to purchase or use Green Lumber, a product promoted and sold for male sexual enhancement on various websites, including www.getgreenlumber.com (redirects to www.greenlumber.com), and possibly in some retail stores.

FDA In Brief: FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse
Fri, 20 Sep 2019 12:24:50 EDT

FDA approves new packaging for brand-name over-the-counter loperamide to help curb abuse and misuse

La FDA advierte sobre la inflamación pulmonar poco frecuente, pero grave con Ibrance, Kisqali y Verzenio para el cáncer de mama
Fri, 20 Sep 2019 12:21:18 EDT

La FDA advierte sobre la inflamación pulmonar poco frecuente, pero grave con Ibrance, Kisqali y Verzenio para el cáncer de mama

FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use
Fri, 20 Sep 2019 11:06:57 EDT

FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use

FDA approves first oral GLP-1 treatment for type 2 diabetes
Fri, 20 Sep 2019 10:18:18 EDT

FDA approves Rybelsus (semaglutide) oral tablets to improve blood sugar in adults with type 2 diabetes, with diet and exercise. It is first GLP-1 receptor protein treatment approved in U.S.

Recently Issued Guidance Documents
Fri, 20 Sep 2019 08:53:30 EDT

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP
Fri, 20 Sep 2019 07:03:55 EDT

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity.

May 8, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement - 05/08/2019 - 05/08/2019
Thu, 19 Sep 2019 17:06:07 EDT

May 8, 2019: Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement

Drug Shortages | Additional News and Information
Thu, 19 Sep 2019 16:22:16 EDT

Drug Shortages: Additional News and Information

Drug Shortages
Thu, 19 Sep 2019 16:10:11 EDT

Drug Shortages homepage

"Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue
Thu, 19 Sep 2019 16:06:33 EDT

"Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue

Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 - 09/25/2019 - 09/26/2019
Thu, 19 Sep 2019 15:52:46 EDT

As a continuation from the 2018 workshop on complex generic drug products, this science-focused workshop communicates to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development.

Guidance and Other Information of Special Interest to MCM Stakeholders
Thu, 19 Sep 2019 15:23:43 EDT

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

MCM-Related Guidance by Date
Thu, 19 Sep 2019 15:23:14 EDT

Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date

Whats New Vaccines Blood Biologics RSS Feed

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products
Fri, 20 Sep 2019 14:35:46 EDT

Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products, Draft Guidance, Level 1, CBER, CDER Biologics, Drugs, September 2019

What’s New for Biologics
Fri, 20 Sep 2019 09:40:11 EDT

Latest news from the Center for Biologics Evaluation and Research

The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
Fri, 20 Sep 2019 09:22:02 EDT

FDA issues draft guidance on the Accreditation Scheme for Conformity Assessment (ASCA) Pilot for Industry, Accreditation Bodies, Testing Laboratories, and FDA.

Recently Issued Guidance Documents
Fri, 20 Sep 2019 08:53:30 EDT

This page lists Recently Issued CBER and Cross-Center Guidance Documents.

Clinical Guidances
Fri, 20 Sep 2019 08:53:24 EDT

This page lists Clinical Guidance documents.

Cleared 510(k) Submissions with Supporting Documents - 2019
Thu, 19 Sep 2019 16:08:21 EDT

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

Guidance and Other Information of Special Interest to MCM Stakeholders
Thu, 19 Sep 2019 15:23:43 EDT

Information of particular interest to sponsors/applicants of medical countermeasures to treat, prevent, diagnose, and detect chemical, biological, radiological, and nuclear threats and emerging infectious diseases

MCM-Related Guidance by Date
Thu, 19 Sep 2019 15:23:14 EDT

Guidances and other information of special interest to MCM stakeholders, sponsors and applicants, listed by date

Devices Guidances
Thu, 19 Sep 2019 15:15:28 EDT

This page lists Medical Device Guidance documents.

FDA Voices: Perspectives From FDA Leadership and Experts
Thu, 19 Sep 2019 12:53:39 EDT

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

Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019
Thu, 19 Sep 2019 12:50:43 EDT

This is the main page for the Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement.

FDA Voices on Policy
Thu, 19 Sep 2019 11:15:50 EDT

FDA Voices on Policy

Flucelvax Quadrivalent
Thu, 19 Sep 2019 10:07:56 EDT

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.

FDA’s Comprehensive Response to HIV — Part I
Thu, 19 Sep 2019 09:45:27 EDT

A multidisciplinary review and oversight program helps spur the development of effective treatments and approval of an expanding number of HIV drugs and drug combinations.

FDA’s Comprehensive Response to HIV — Part II
Thu, 19 Sep 2019 09:38:59 EDT

FDA plays a pivotal role in advancing HIV therapies in underserved global markets through the President’s Emergency Plan for AIDS Relief (PEPFAR).

Safety and Performance Based Pathway
Thu, 19 Sep 2019 08:38:29 EDT

Current thinking on expanding the concept of the Abbreviated 510(k) Program for demonstrating substantial equiv. for premarket notification 510(k) submissions.

Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Wed, 18 Sep 2019 11:55:18 EDT

Links to the different types of Donor Screening Assays. A table for each assay is provided with detailed information such as tradename, infectious agent, format, specimen, use, manufacturer, approval date, and STN.

DENGVAXIA
Wed, 18 Sep 2019 09:45:21 EDT

DENGVAXIA is Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Section 8400: Marketing Applications
Wed, 18 Sep 2019 09:30:05 EDT

This is the SOPP Section 8400: Marketing Applications main page.

Safer Technologies Program for Medical Devices
Wed, 18 Sep 2019 08:25:30 EDT

A new, voluntary program for medical devices that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics.


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