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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 first therapy to treat patients with rare blood disorder
Fri, 08 Nov 2019 12:28:56 EST

FDA grants approval to Reblozyl (luspatercept–aamt) for the treatment of anemia in adult patients with beta thalassemia who require regular red-blood cell transfusions.

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.

Food and Drugs Administration--Recalls/Safety Alerts

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Tue, 12 Nov 2019 14:13:31 EST

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg


Taher Voluntarily Recalls Veggie & Ranch Cups With Cauliflower Because of Possible Health Risk
Tue, 12 Nov 2019 14:09:02 EST

Taher, Inc., in conjunction with Mann Packing Co., as part of a multi-state recall due to the potential risk of Listeria monocytogenes, in an abundance of caution is announcing a voluntary recall of vegetable cups served in select locations in Minnesota.

Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
Tue, 12 Nov 2019 09:42:04 EST

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.

Russ Davis Wholesale Voluntarily Recalling Products Due to Possible Health Risk
Fri, 08 Nov 2019 19:19:43 EST

Russ Davis Wholesale (RDW), a leading fresh produce processor and distributor, in an abundance of caution is voluntarily recalling multiple products due to possible contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or

Mann Packing Co., Inc. Voluntarily Recalls Vegetable Products Sold in the United States and Canada Due to Potential Health Risks
Fri, 08 Nov 2019 18:04:08 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.

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Fri, 08 Nov 2019 17:14:31 EST

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f

Mann Packing Recall of Vegetable Products Affects Whole Foods Market Stores; Grocer Issues Voluntary Recall of Multiple Products
Fri, 08 Nov 2019 15:47:13 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

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.

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.

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.

What's New: Drugs RSS Feed

Recently Issued Guidance Documents
Wed, 13 Nov 2019 09:09:11 EST

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

Mylan Laboratories Limited - Unit 8 - 589297 - 11/05/2019
Wed, 13 Nov 2019 06:04:33 EST

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

What's New Related to Drugs
Tue, 12 Nov 2019 17:54:41 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.

Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States - 11/18/2019 - 11/19/2019
Tue, 12 Nov 2019 16:36:21 EST

Public Workshop

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
Tue, 12 Nov 2019 15:43:35 EST

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

"Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue
Tue, 12 Nov 2019 14:21:45 EST

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

Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making - 12/06/2019 - 12/06/2019
Tue, 12 Nov 2019 14:21:22 EST

The U.S Food and Drug Administration (FDA) is hosting a public workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders.

"Research Investigational New Drug Applications – What You Need To Know" June 25, 2019 Issue
Tue, 12 Nov 2019 14:20:53 EST

FDA recently released an update to clarify when ‘Research’ vs. ‘Commercial’ should be selected on FDA Form 1571, and thus when electronic common technical document or “eCTD” requirements would apply for an investigational new drug or “IND” application.

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity
Tue, 12 Nov 2019 14:13:31 EST

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg


Human Drug Compounding
Tue, 12 Nov 2019 12:20:11 EST

Compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.

Sunscreen meetings
Tue, 12 Nov 2019 12:02:44 EST

Sunscreen meetings

Farmville Discount Drug, Inc. DBA Best Value Drug - 574044 - 07/09/2019
Tue, 12 Nov 2019 09:56:05 EST

Compounding Pharmacy/Adulterated Drug Products

Cadila Healthcare Limited - 584856 - 10/29/2019
Tue, 12 Nov 2019 09:56:04 EST

CGMP/Finished Pharmaceuticals/Adulterated


MSM Nutraceuticals, LLC dba MSM Health Solutions - 584018 - 10/24/2019
Tue, 12 Nov 2019 09:56:02 EST

CGMP/Finished Pharmaceuticals/Adulterated

Contacare Ophthalmics & Diagnostics - 570360 - 04/23/2019
Tue, 12 Nov 2019 09:56:01 EST

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved/Misbranded

Swabplus, L.P. - 584803 - 10/31/2019
Tue, 12 Nov 2019 09:56:01 EST

CGMP/Finished Pharmaceuticals/Adulterated


Developing Novel Therapies for Stimulant Use Disorder - 12/16/2019 - 12/16/2019
Tue, 12 Nov 2019 09:55:36 EST

In recent years, there has been an increase in the number of overdoses that involve a psychostimulant, such as methamphetamine, cocaine, or prescription. In response to growing rates of stimulant misuse, addiction, and overdose, stakeholders across the U.S. health care system are working to implement strategies designed to ensure that patients with

Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil
Tue, 12 Nov 2019 09:42:04 EST

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.

Oncologic Drugs Advisory Committee Roster
Tue, 12 Nov 2019 08:13:12 EST

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

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Fri, 08 Nov 2019 17:14:31 EST

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f

Whats New Vaccines Blood Biologics RSS Feed

Devices Guidances
Wed, 13 Nov 2019 09:17:41 EST

This page lists Medical Device Guidance documents.

Recently Issued Guidance Documents
Wed, 13 Nov 2019 09:09:11 EST

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

FluLaval Quadrivalent
Wed, 13 Nov 2019 08:11:11 EST

For active immunization of persons 6 months of age and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

FluLaval
Wed, 13 Nov 2019 07:50:26 EST

Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. FLULAVAL is approved for use in persons 6 months of age and older.

Flucelvax Quadrivalent
Tue, 12 Nov 2019 15:53:46 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.

FLUCELVAX
Tue, 12 Nov 2019 15:39:47 EST

For active immunization of persons 4 years of age and older for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

What’s New for Biologics
Tue, 12 Nov 2019 14:13:45 EST

Latest news from the Center for Biologics Evaluation and Research

Cleared 510(k) Submissions with Supporting Documents - 2019
Tue, 12 Nov 2019 13:55:37 EST

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

Fluarix Quadrivalent
Tue, 12 Nov 2019 12:33:34 EST

For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Fluarix
Tue, 12 Nov 2019 10:49:09 EST

For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.

Strong Fertility Center - 593262 - 10/29/2019
Tue, 12 Nov 2019 09:56:03 EST

Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)

CPG Sec. 110.100 Certification for Exports
Fri, 08 Nov 2019 14:30:27 EST

CPG Sec. 110.100 Certification for Exports

FDA Export Certificates
Fri, 08 Nov 2019 14:09:43 EST

This guidance document is intended to provide a general description of FDA Export Certificates to industry and foreign governments.

Collection of Race and Ethnicity Data in Clinical Trials
Fri, 08 Nov 2019 12:46:39 EST

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

Guidance and Other Information of Special Interest to MCM Stakeholders
Fri, 08 Nov 2019 12:10:19 EST

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
Fri, 08 Nov 2019 12:07:37 EST

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

AFLURIA QUADRIVALENT
Fri, 08 Nov 2019 10:44:05 EST

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Guidance for Industry Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
Fri, 08 Nov 2019 10:43:56 EST

Drug Safety

AFLURIA
Fri, 08 Nov 2019 10:08:51 EST

For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.

Flublok Quadrivalent
Fri, 08 Nov 2019 09:20:12 EST

Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.


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