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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 the agency’s efforts to protect patients through postmarket drug safety surveillance practices
Wed, 06 Nov 2019 15:24:27 EST

Today, the FDA is issuing an update on efforts to protect patients through postmarket drug safety surveillance practices

FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
Tue, 05 Nov 2019 14:32:07 EST

Today, the FDA authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. It is the first HIV drug resistance assay that uses NGS that the FDA has authorized for marketing in the U.S.

Statement on new testing results, including low levels of impurities in ranitidine drugs
Fri, 01 Nov 2019 15:49:50 EDT

Today, the FDA is issuing an update on new testing results, including low levels of impurities in ranitidine drugs

USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance
Wed, 30 Oct 2019 14:06:11 EDT

New partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.

Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts
Tue, 29 Oct 2019 16:33:04 EDT

FDA is taking steps towards requiring electronic submission of certain safety reports under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).

Statement on FDA’s new report regarding root causes and potential solutions to drug shortages
Tue, 29 Oct 2019 10:45:40 EDT

Today, the FDA is issuing a report on causes and solutions to drug shortages

FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
Mon, 28 Oct 2019 13:21:02 EDT

The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved products containing cannabidiol with unsubstantiated claims.

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
Fri, 25 Oct 2019 14:55:43 EDT

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
Fri, 25 Oct 2019 14:46:13 EDT

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc.

Statement on concerns with medical device availability due to certain sterilization facility closures
Fri, 25 Oct 2019 12:30:53 EDT

In light of the possibility of continued ethylene oxide sterilization facility closures, FDA is again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.

Baby powder manufacturer voluntarily recalls products for asbestos
Fri, 25 Oct 2019 10:51:09 EDT

The FDA is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.

Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants
Thu, 24 Oct 2019 17:43:02 EDT

FDA statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products
Thu, 24 Oct 2019 17:19:42 EDT

Today, the FDA is taking two new steps toward clarifying the agency’s approach on homeopathic products.

FDA approves new breakthrough therapy for cystic fibrosis
Thu, 24 Oct 2019 17:11:08 EDT

FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, estimated to represent 90% of the cystic fibrosis population.

Statement on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis
Thu, 24 Oct 2019 11:50:11 EDT

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

FDA grants first-ever modified risk orders to eight smokeless tobacco products
Tue, 22 Oct 2019 15:11:15 EDT

The FDA announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Fri, 18 Oct 2019 15:18:20 EDT

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs
Wed, 16 Oct 2019 12:52:55 EDT

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs

FDA approves new treatment for patients with migraine
Fri, 11 Oct 2019 14:20:02 EDT

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens
Thu, 10 Oct 2019 13:40:22 EDT

Today, FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test FDA has allowed to be marketed in the U.S. for Ebola Virus Disease (EVD).

Food and Drugs Administration--Recalls/Safety Alerts

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity
Thu, 07 Nov 2019 17:28:39 EST

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in

Peekay International Inc., Issues Alert on Underclared Sulfites in “Swan Dry Yellow Dates” and “Keshav Dry Yellow Dates”
Thu, 07 Nov 2019 15:32:43 EST

Peekay International Inc. 56 12 56th Street, Maspeth, NY is recalling its 7 ounce and 14 ounce packages of “SWAN DRY YELLOW DATES” and “KESHAV DRY YELLOW DATES” food treats because they contained undeclared sulfites.

Mann Packing Recall of Vegetable Products Affects Whole Foods Market Stores; Grocer Issues Voluntary Recall of Multiple Products
Wed, 06 Nov 2019 17:54:51 EST

In response to Mann Packing Co., Inc’s recall of vegetable products, Whole Foods Market is voluntarily recalling multiple products from its stores in the United States. Mann Packing issued the recall because the vegetables may be contaminated with Listeria monocytogenes. No illnesses have been repor

ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter
Wed, 06 Nov 2019 17:48:21 EST

ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.

Mill Stream Corp. (Sullivan Harbor Farm) Issues a Voluntary Recall of Cold Smoked Salmon Because of Possible Health Risk
Wed, 06 Nov 2019 17:34:59 EST

Mill Stream Corp. (Sullivan Harbor Farm) of Hancock, Maine is voluntarily recalling ten lots of Cold Smoked Salmon because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product

Meijer Recalls Select Vegetable Trays Due to Potential Health Risk
Wed, 06 Nov 2019 16:31:24 EST

Meijer, in conjunction with Mann Packing Co., as part of a multi-state recall due to the potential risk of Listeria monocytogenes, is announcing a voluntary recall of select vegetable trays in various weights ranging from 7 oz. to 2 lbs. and broccoli florets served on salad bars at two stores.

Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance
Wed, 06 Nov 2019 11:27:51 EST

Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann

Ghnw, LLC Voluntarily Recalls Mushroom Stir Fry Blend and Stir Fry Blend Because of Possible Health Risk in Oregon and Washington States
Tue, 05 Nov 2019 20:43:30 EST

GHNW, LLC of Clackamas, OR is voluntarily recalling Mushroom Stir Fry Blend 10 oz. tray and Stir Fry Blend 16 oz. tray that were produced using Broccoli Slaw that is being recalled by Mann Packing Co., Inc. due to the potential to be contaminated with Listeria monocytogenes.

Wegmans Veggie Power Blend & Tofu Shiitake Slaw
Tue, 05 Nov 2019 14:55:18 EST

The products are being recalled because they have the potential to be contaminated with Listeria monocytogenes.

Mann Packing Co., Inc. Voluntarily Recalls Vegetable Products Sold in the United States and Canada Due to Potential Health Risks
Sun, 03 Nov 2019 22:47:03 EST

The voluntary recall is a response to a notification by the Food and Drug Administration and the Canadian Food Inspection Agency of a potential contamination with Listeria monocytogenes.

Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products
Fri, 01 Nov 2019 17:04:52 EDT

Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.

Golden Dragon Fortune Cookies Inc. Issues Allergy Alert on Undeclared Milk in Chinese Almond Cookies
Fri, 01 Nov 2019 16:31:32 EDT

Golden Dragon Fortune Cookies Inc., of Chicago, Illinois is recalling Golden Dragon Inc. Chinese Almond Cookies, because it may contain undeclared Milk.

In Association with ADM Milling Co, King Arthur Flour, Inc. Expands Recall of Unbleached All-Purpose Flour (5 Lb & 25 Lb)
Fri, 01 Nov 2019 11:53:08 EDT

In association with ADM Milling Company, King Arthur Flour, Inc., announced today a voluntary national recall of specific lots of its Unbleached All-Purpose Flour (5 lb. & 25 lb.) We are taking this voluntary precautionary step because of the potential presence of E. coli 026 which was discovered

King Arthur Flour Updates Three Lot Codes of Voluntarily Recalled Unbleached All-Purpose Flour (5 lb.)
Fri, 01 Nov 2019 11:52:41 EDT

King Arthur Flour, Inc. was notified by ADM Milling Co. that three additional product lot codes of Unbleached All-Purpose Flour 5 lb. were omitted from the original data they provided for the press release on October 3, 2019. The additional lot codes and their corresponding “Best Used By” dates are

Nestlé USA Announces Voluntary Recall of Ready-to-Bake Refrigerated Cookie Dough Products Due to Potential Presence of Foreign Material
Thu, 31 Oct 2019 20:48:40 EDT

Nestlé USA is initiating a voluntary recall of ready-to-bake refrigerated Nestlé Toll House Cookie Dough products due to the potential presence of food-grade rubber pieces.

Wawona Frozen Food Voluntarily Recalls Frozen Raspberries Due to Possible Health Risk
Thu, 31 Oct 2019 11:28:27 EDT

Wawona Frozen Foods is voluntarily recalling packages of frozen raspberries and frozen berry mixes containing raspberries sold at Aldi Grocery Stores and frozen raspberries sold at Raley's Family of Fine Stores because they have the potential to be contaminated with Hepatitis A.

Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
Tue, 29 Oct 2019 14:25:14 EDT

Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup

North Bay Produce Voluntarily Recalls Fresh Apples Because of Possible Health Risk
Mon, 28 Oct 2019 22:03:05 EDT

North Bay Produce, Inc. of Traverse City, Michigan is voluntarily recalling 2,297 cases and 2 bulk bins of fresh apples due to the potential to be contaminated with Listeria monocytogenes.

Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market
Mon, 28 Oct 2019 16:22:39 EDT

Nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA

Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance
Sat, 26 Oct 2019 19:01:51 EDT

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance

What's New: Drugs RSS Feed

Phonetic and Orthographic Computer Analysis (POCA) Program
Thu, 07 Nov 2019 18:39:34 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.

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity
Thu, 07 Nov 2019 17:28:39 EST

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in

October 29, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement - 10/29/2019 - 10/29/2019
Thu, 07 Nov 2019 17:24:51 EST

October 29, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement

What You Should Know About Using Cannabis, Including CBD, When Pregnant or Breastfeeding
Thu, 07 Nov 2019 16:41:54 EST

FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding.


Men With Breast Cancer Need More Treatment Options and Access to Genetic Counseling
Thu, 07 Nov 2019 16:29:12 EST

Breast cancer in men tends to be diagnosed at an older age and when the cancer is at a later stage, but is treated very similarly to breast cancer in women. The FDA encourages the inclusion of men in breast cancer clinical trials.

What's New Related to Drugs
Thu, 07 Nov 2019 15:13:04 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.

Drug Trials Snapshots: REYVOW
Thu, 07 Nov 2019 15:08:27 EST

REYVOW is a drug used for the acute treatment of migraine with or without aura in adults. A migraine is a type of headache that, is associated with pain nausea, vomiting, and sensitivity to light or sound. Patients develop temporary visual or other signs and symptoms prior to headache onset.

Drug Trials Snapshots
Thu, 07 Nov 2019 14:59:23 EST

Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent. Drug Trials Snapshots provide consumers with information about who participated in clinical trials that supported the FDA approval of new drugs. The information provided in these Snapshots also highlights whether there were any differences in the benefits and side effects among sex, race and age groups.

JumpStarting Drug Review
Thu, 07 Nov 2019 14:45:41 EST

JumpStart runs a series of drug clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers better understand the data and have the information to conduct an effective evaluation of the drug submission.

2019 Drug Safety Communications
Thu, 07 Nov 2019 14:25:00 EST

2019 Drug Safety Communications

FDA Voices: Perspectives From FDA Leadership and Experts
Thu, 07 Nov 2019 13:32:35 EST

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

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)
Thu, 07 Nov 2019 11:55:49 EST

Get updates on the recalls

FDA Voices on Policy
Thu, 07 Nov 2019 10:51:36 EST

FDA Voices on Policy

Endocrinologic and Metabolic Drugs Advisory Committee Roster
Thu, 07 Nov 2019 10:37:15 EST

Advisory Committees (Drugs)

Patient Listening Sessions
Thu, 07 Nov 2019 10:34:06 EST

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making - 11/18/2019 - 11/18/2019
Thu, 07 Nov 2019 10:11:20 EST

Meeting: Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making

Patient Perspective Is Vital to FDA's Work
Thu, 07 Nov 2019 10:09:02 EST

FDA considers patients the real experts when it comes to their own health condition. Rare disease patient listening sessions are one more way FDA is engaging patients in all of the steps of the discovery and development process for medical products.

Collection of Race and Ethnicity Data in Clinical Trials
Thu, 07 Nov 2019 09:29:45 EST

Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials

ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter
Wed, 06 Nov 2019 17:48:21 EST

ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.

Consumer Updates
Wed, 06 Nov 2019 15:52:28 EST

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

Whats New Vaccines Blood Biologics RSS Feed

What’s New for Biologics
Thu, 07 Nov 2019 15:45:59 EST

Latest news from the Center for Biologics Evaluation and Research

Jobs at the Center for Biologics Evaluation and Research (CBER)
Thu, 07 Nov 2019 15:44:42 EST

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics.

Cleared 510(k) Submissions with Supporting Documents - 2019
Thu, 07 Nov 2019 14:40:41 EST

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

Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement - 09/13/2019 - 09/13/2019
Thu, 07 Nov 2019 13:52:42 EST

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

Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement - 10/09/2019 - 10/09/2019
Thu, 07 Nov 2019 13:39:10 EST

This is the CBER Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement.

FDA Voices: Perspectives From FDA Leadership and Experts
Thu, 07 Nov 2019 13:32:35 EST

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

Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement - 03/20/2019 - 03/21/2019
Thu, 07 Nov 2019 13:22:00 EST

This is the CBER Blood Products Advisory Committee March 20 - 21, 2019 Meeting Announcement.

2018 Meeting Materials, Blood Products Advisory Committee
Thu, 07 Nov 2019 13:14:34 EST

This is the main page for the 2018 Meeting Materials, Blood Products Advisory Committee.

July 18-19, 2018: Blood Products Advisory Committee Meeting Announcement - 07/17/2018 - 07/18/2018
Thu, 07 Nov 2019 13:13:20 EST

This is the Meeting Announcement for the July 18-19, 2018, Blood Products Advisory Committee (BPAC) Meeting.

Blood Products Advisory Committee November 22, 2019 Meeting Announcement - 11/22/2019 - 11/22/2019
Thu, 07 Nov 2019 13:02:05 EST

This is the CBER Blood Products Advisory Committee November 22, 2019 Meeting Announcement.

BR190330 - Sentosa SQ HIV-1 Genotyping Assay
Thu, 07 Nov 2019 12:28:47 EST

A next generation sequencing-based in vitro diagnostic test intended for use in detecting HIV-1 genomic mutations (in the protease, reverse transcriptase and integrase regions of the pol gene) as an aid in monitoring and treating HIV-1 infection.

FDA Voices on Policy
Thu, 07 Nov 2019 10:51:36 EST

FDA Voices on Policy

Patient Listening Sessions
Thu, 07 Nov 2019 10:34:06 EST

Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition.

Patient Perspective Is Vital to FDA's Work
Thu, 07 Nov 2019 10:09:02 EST

FDA considers patients the real experts when it comes to their own health condition. Rare disease patient listening sessions are one more way FDA is engaging patients in all of the steps of the discovery and development process for medical products.

Collection of Race and Ethnicity Data in Clinical Trials
Thu, 07 Nov 2019 09:29:45 EST

Guidance for Industry and FDA Staff - Collection of Race and Ethnicity Data in Clinical Trials

Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement - 11/08/2019 - 11/08/2019
Wed, 06 Nov 2019 16:48:45 EST

This is the CBER Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement.

INFANRIX
Wed, 06 Nov 2019 16:38:27 EST

Product approval information for Diphtheria Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed also known as Infanrix.

KINRIX
Wed, 06 Nov 2019 16:21:57 EST

Changes to your package insert to the Dosage and Administration section regarding visual inspection by the user for cracked vials or syringes prior to administration of the vaccine and non-use of product should those conditions exist.

Consumer Updates
Wed, 06 Nov 2019 15:52:28 EST

Get timely, reliable, health and safety information about food, drugs, medical devices, vaccines, pet food, pet medicine and more.

Recently Issued Guidance Documents
Wed, 06 Nov 2019 11:37:10 EST

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


Here are some headlines supporting the benefits of a system like ADERS ®:



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