Barcode Five Rights System



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

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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 ®.





Current Patient Safety and Drug Safety Updates from the FDA


FDA Press Releases RSS Feed

FDA Authorizes Software that Can Help Identify Prostate Cancer
Tue, 21 Sep 2021 13:54:08 EDT

  FDA authorizes software to assist pathologists detect areas that are suspicious for cancer as an adjunct to the standard of care review of digitally-scanned slide images from prostate biopsies.

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
Mon, 20 Sep 2021 11:04:05 EDT

  FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

FDA In Brief: FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs
Mon, 20 Sep 2021 10:27:23 EDT

  Today, the FDA posted an initial batch of four deemed final administrative orders as part of the Over-the-Counter Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act

Coronavirus (COVID-19) Update: September 17, 2021
Fri, 17 Sep 2021 15:05:22 EDT

  Coronavirus (COVID-19) Update: September 17, 2021

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions
Fri, 17 Sep 2021 11:53:36 EDT

  A Federal court has entered a consent decree against a Florida compounder, prohibiting the manufacture and distribution of drugs due to insanitary conditions

FDA In Brief: FDA Hosts Third Summit Focused on Reducing the Availability of Opioids Online
Fri, 17 Sep 2021 10:56:35 EDT

  The U.S. Food and Drug Administration hosted its third Online Opioid Summit, “Reducing the Availability of Opioids Online,” as part of the agency’s efforts to address the illegal availability of opioids online.

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation
Wed, 15 Sep 2021 15:25:22 EDT

  The FDA announces reorganization of the information technology, data and cybersecurity offices into the agency-level Office of Digital Transformation and Vid Desai as the agency’s Chief Information Officer.

FDA In Brief: FDA Announces Winners of Food Traceability Challenge
Mon, 13 Sep 2021 10:56:20 EDT

  FDA announces winners of New Era of Smarter Food Safety Low- or No-Cost Tech-enabled Traceability Challenge

Coronavirus (COVID-19) Update: September 10, 2021
Fri, 10 Sep 2021 15:23:15 EDT

  Coronavirus (COVID-19) Update: September 10, 2021

FDA Will Follow The Science On COVID-19 Vaccines For Young Children
Fri, 10 Sep 2021 09:21:33 EDT

  FDA leadership outlines steps the FDA will take to ensure the safety and efficacy of COVID-19 vaccines for young children

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted
Thu, 09 Sep 2021 14:31:30 EDT

  FDA made significant progress since Sept, 9, 2020, working diligently to better understand these ENDS products and have taken action on about 93% of the total timely-submitted applications.

FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes
Thu, 09 Sep 2021 12:28:43 EDT

  Today, the FDA and FTC posted warning letters to 10 companies for selling dietary supplements claiming to treat diabetes

FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks
Thu, 09 Sep 2021 11:13:54 EDT

  The FDA will meet with members of the food industry, regulatory counterparts at all levels of government, consumers, and others to enhance our understanding of how human and animal foods are sold through e-commerce business models.

FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids
Wed, 08 Sep 2021 10:59:38 EDT

  The FDA announces a two-day public workshop to give stakeholders an opportunity to provide input on aspects of the current opioid crisis that could be mitigated in a measurable way by requiring mandatory prescriber education as part of a REMS.

Coronavirus (COVID-19) Update: September 7, 2021
Tue, 07 Sep 2021 16:06:05 EDT

  Coronavirus (COVID-19) Update: September 7, 2021

FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals
Thu, 02 Sep 2021 11:14:40 EDT

  FDA In Brief: FDA Reaches Milestone in Competitive Generic Therapy Drug Approvals, Marking Success of Program that Encourages Development of Drugs with Inadequate Generic Competition

FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
Wed, 01 Sep 2021 16:54:35 EDT

  FDA announced a virtual VRBPAC meeting to discuss the Pfizer-BioNTech supplemental application for a third (“booster”) dose of Comirnaty (COVID-19 Vaccine, mRNA).

Coronavirus (COVID-19) Update: August 31, 2021
Tue, 31 Aug 2021 15:11:49 EDT

  Coronavirus (COVID-19) Update: August 31, 2021

Coronavirus (COVID-19) Update: August 27, 2021
Fri, 27 Aug 2021 15:18:15 EDT

  Coronavirus (COVID-19) Update: August 27, 2021

FDA Approves First-of-Its-Kind Stroke Rehabilitation System
Fri, 27 Aug 2021 10:54:25 EDT

  The FDA approved the MicroTransponder Vivistim Paired VNS System, a rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke using vagus nerve stimulation.

Food and Drugs Administration--Recalls/Safety Alerts

IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance
Mon, 20 Sep 2021 15:14:00 EDT

  Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting

Joy Gourmet Foods LLC Issues Allergy Alert on Undeclared Sulfites, Coconut and FD&C Yellow#5
Sat, 18 Sep 2021 00:00:00 EDT

  Joy Gourmet Foods Inc. of Maspeth, NY is recalling its Joy Brand.Coriander chutney because it contains undeclared sulfites.coconut. FD&C YELLOW#5 . People who have allergies to sulfites.coconut and FD&C YELLOW#5 run the risk of serious or life-threatening allergic reaction if they consume this produ

Green Field Farms Dairy Issues Voluntary Recall of Whole Chocolate Milk
Fri, 17 Sep 2021 00:00:00 EDT

  Green Field Farms Dairy of Fredericksburg, Ohio announces a voluntary recall of its Whole Chocolate Milk product, with a code date of 9/29/21, due to a laboratory analysis that indicated this product was not effectively pasteurized. 1,242 units of the affected product were distributed in Ohio, India

Drew’s Organics, LLC Issues Voluntary Recall of Aldi Simply Nature Organic Poppy Seed Dressing for Potential Clostridium botulinum Contamination
Thu, 16 Sep 2021 17:15:00 EDT

  Drew’s Organics, LLC of Chester, VT is voluntarily recalling one lot code of Aldi Simply Nature Organic Poppy Seed Dressing due to a processing issue that could allow for microbial growth.

Updated: Baker Farms Recalls Various Brand Name of Kale Due to Listeria Monocytogenes Contamination
Thu, 16 Sep 2021 00:00:00 EDT

  Baker Farms is recalling their Baker Farms, Kroger & SEG Grocers brand names of Kale, 1 lb plastic bags with BEST BY 09-18-2021 107020-21832 due to contamination of Listeria monocytogenes. Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children,

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Thu, 16 Sep 2021 00:00:00 EDT

  Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer

The Kroger Co. Issues Voluntarily Recall on 16-Ounce Kroger Bagged Kale Due to Possible Listeria Monocytogenes Contamination
Thu, 16 Sep 2021 00:00:00 EDT

  The Kroger Co. (NYSE: KR) is voluntarily recalling its 16-ounce Kroger bagged kale product, produced by Baker Farms, due to possible listeria monocytogenes contamination. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly

Seviroli Foods Voluntarily Issues a Recall of H-E-B Jumbo Stuffed Shells - 22 Oz Due to Potential Presence of Foreign Material
Tue, 14 Sep 2021 00:00:00 EDT

  Committed to the quality of its products and out of an abundance of caution, SEVIROLI FOODS, INC, of Bellmawr, NJ is recalling H-E-B Jumbo Stuffed Shells - 22 oz due to potential presence of foreign material in product (Metal). Consumption of hard or sharp foreign material could cause physical injur

Buurma Farms Inc. Recalls Plain (Flat) Parsley Due to Possible Health Risks
Tue, 14 Sep 2021 00:00:00 EDT

  Buurma Farms Inc. of Willard, OH, is voluntarily recalling 320 boxes of its Plain Parsley after testing showed possible contamination with Shiga-toxin producing E.coli. The product being recalled is Buurma Plain (flat leaf) Parsley with a harvest date of August 30, 2021 from their Gregory, Michigan

Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® (amifampridine) 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination
Mon, 13 Sep 2021 00:00:00 EDT

  Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily

Velvet Ice Cream Voluntarily Recalls Raspberry Fudge Cordial Ice Cream Due to Undeclared Peanuts
Mon, 13 Sep 2021 00:00:00 EDT

  Velvet Ice Cream has issued a voluntary recall of its 56oz Raspberry Fudge Cordial Ice Cream because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts could experience a serious or life-threatening allergic reaction if they consume this product. The impac

Dole Fresh Vegetables Announces Precautionary Limited Recall of Curly Leaf Parsley Due to Possible Contamination with Non-O157 Shiga-Toxin Producing E. coli
Fri, 10 Sep 2021 18:38:00 EDT

  Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of conventional Curly Leaf Parsley. The product being recalled is Dole® Curly Leaf Parsley, with harvest dates of August 18, 2021, and August 19, 2021. A random, routine regulatory sample collected in Michigan tested po

McKee Foods Issues Allergy Alert on Undeclared Pecans in Little Debbie® Mini Nutty Buddy Cookie Bites Sandwich Cookies
Fri, 10 Sep 2021 12:47:00 EDT

  McKee Foods of Collegedale, Tenn., is recalling 25 cases of Little Debbie® Mini Nutty Buddy Cookie Bites Sandwich Cookies, because they may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they cons

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit
Wed, 08 Sep 2021 00:00:00 EDT

  Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (“Firvanq®”) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omepraz

ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the Presence of Particulate Matter
Fri, 03 Sep 2021 17:12:00 EDT

  ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other

Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency
Fri, 03 Sep 2021 12:10:00 EDT

  Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-m

Weis Markets Issues an Allergy Alert for $7 Crab Cake Meal Due to Undeclared Milk Allergen
Thu, 02 Sep 2021 17:17:00 EDT

  Weis Markets today announced it has issued a recall for its in-store $7 Crab Cake Meal for not declaring milk as an allergen on its label. Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen. Even a tiny amount of the allergy-causing food can tri

The Baking Institute Bakery Co. Issues Allergen Alert on Undeclared Walnuts, Coconuts and Milk in “Carrot Cake”
Thu, 02 Sep 2021 16:34:00 EDT

  The Baking Institute Bakery Co. of Northbrook, Illinois is recalling “Carrot Cake” because it may contain undeclared walnuts and coconut. People who have an allergy or severe sensitivity to walnuts and coconut run the risk of serious or life-threatening allergic reaction if they consume these produc

Magellan Diagnostics, Inc. Expands Voluntary Recall of LeadCare® Test Kits
Wed, 01 Sep 2021 12:07:00 EDT

  Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead T

Rocky Top Farms Issues Allergy Alert on Undeclared Milk in “Cherry Butter”
Thu, 26 Aug 2021 12:24:00 EDT

  Rocky Top Farms of Ellsworth, MI, is recalling its 10-ounce jars of "Cherry Butter" fruit butter because they may contain undeclared milk. People who have an allergy or a severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

What's New: Drugs RSS Feed

Advancing Generic Drug Development: Translating Science to Approval - 09/21/2021 - 09/22/2021
Tue, 21 Sep 2021 19:14:12 EDT

  KEYNOTE SPEAKER - Janet Woodcock MD, Acting Commissioner of FDA

Rosuvastatin Calcium (marketed as Crestor) Information
Tue, 21 Sep 2021 18:01:42 EDT

  Rosuvastatin Calcium (marketed as Crestor) Information

What's New Related to Drugs
Tue, 21 Sep 2021 16:55:15 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.

IntegraDose Compounding Services, LLC Issues Voluntary Nationwide Recall of Cefazolin Injection Products Due to a Lack of Sterility Assurance
Tue, 21 Sep 2021 15:44:05 EDT

  Minneapolis, Minnesota, IntegraDose Compounding Services is voluntarily recalling nine lots, listed in the table below, of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance resulting

Generic Drug Facilities, Sites and Organization Lists
Tue, 21 Sep 2021 11:47:23 EDT

  Generic Drug Facilities, Sites and Organization Lists

Oncology (Cancer) / Hematologic Malignancies Approval Notifications
Tue, 21 Sep 2021 11:35:40 EDT

  Oncology (Cancer) / Hematologic Malignancies Approval Notifications

FDA grants accelerated approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer
Tue, 21 Sep 2021 11:35:23 EDT

  FDA granted accelerated approval to tisotumab vedotin-tftv (Tivdak, Seagen Inc.) for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Import Tolerances for Residues of Unapproved New Animal Drugs in Food (Final Rule) Regulatory Impact Analysis
Tue, 21 Sep 2021 09:48:57 EDT

  Regulatory Impact Analysis of the FDA final rule Import Tolerances for Residues of Unapproved New Animal Drugs in Food

Furley Bioextracts SDN BHD - 614592 - 09/13/2021
Tue, 21 Sep 2021 09:20:08 EDT

  CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Nanomateriales Químicos Avanzados, S.A. de C.V. - 609969 - 09/15/2021
Tue, 21 Sep 2021 09:20:08 EDT

  CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Laboratorio Pharma International SRL - 614766 - 09/15/2021
Tue, 21 Sep 2021 09:20:07 EDT

  CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated

Fibromyalgia Treatment Group - 614183 - FTG, LLC
Tue, 21 Sep 2021 09:20:07 EDT

  New Drug/Misbranded

2016 SBIA Workshops
Mon, 20 Sep 2021 17:30:05 EDT

  2016 SBIA Workshops

2021 FDA/PDA Joint Regulatory Conference - 09/27/2021 - 09/29/2021
Mon, 20 Sep 2021 17:22:46 EDT

  2021FDA/PDA Joint Regulatory Conference

Patient Engagement Collaborative
Mon, 20 Sep 2021 16:29:32 EDT

  The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP).

Compounding Activities | COVID-19
Mon, 20 Sep 2021 12:50:57 EDT

  Providing guidance on compounded drugs

Biosimilar Product Information
Mon, 20 Sep 2021 12:13:52 EDT

  This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs.

Consumer Updates
Mon, 20 Sep 2021 12:12:20 EDT

  Science-based health and safety information you can trust.

Newly Added Guidance Documents
Mon, 20 Sep 2021 11:38:04 EDT

  Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.

Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry
Mon, 20 Sep 2021 11:32:32 EDT

  Pharmaceutical Qualiity Guidance

Whats New Vaccines Blood Biologics RSS Feed

Biosimilars Guidances
Tue, 21 Sep 2021 15:32:31 EDT

  This page lists Biosimilars Guidance documents.

COVID-19 Vaccines
Tue, 21 Sep 2021 13:57:55 EDT

  FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines.

CEPROTIN
Tue, 21 Sep 2021 13:16:30 EDT

  Product approval information is indicated for patients with Severe Congenital Protein C Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.

Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement - 09/02/2021 - 09/03/2021
Tue, 21 Sep 2021 09:56:06 EDT

  This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee September 2-3, 2021 Meeting Announcement.

Patient Engagement Collaborative
Mon, 20 Sep 2021 16:29:32 EDT

  The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Office of Patient Affairs in the Office of Clinical Policy and Programs (OCPP).

What’s New for Biologics
Mon, 20 Sep 2021 16:16:22 EDT

  Latest news from the Center for Biologics Evaluation and Research

CANDIN
Mon, 20 Sep 2021 15:34:26 EDT

  Submission Tracking Number (STN) BL 103257/5066 has been assigned to your recent supplement to your biologics license application for Candida albicans Skin Test Antigen for Cellular Hypersensitivity, CANDIN®, dated April 5, 2016. Your submission is in the form of a “Supplement – Changes Being Effected” as described under 21 CFR 601.12(c)(5).

BIMO/Team Biologics/Internet Surveillance/Other
Mon, 20 Sep 2021 14:12:03 EDT

  This is the main page for the CBER BIMO/Team Biologics/Internet Surveillance/Other.

Consumer Updates
Mon, 20 Sep 2021 12:12:20 EDT

  Science-based health and safety information you can trust.

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
Fri, 17 Sep 2021 18:14:21 EDT

  Information about the Comirnaty and Pfizer-BioNTech COVID-19 Vaccine

Coronavirus (COVID-19) Update: September 17, 2021
Fri, 17 Sep 2021 15:05:22 EDT

  Coronavirus (COVID-19) Update: September 17, 2021

Biologics PREA Reviews and Labeling Changes
Fri, 17 Sep 2021 10:47:13 EDT

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

Comirnaty
Fri, 17 Sep 2021 09:53:32 EDT

  Vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) in individuals 16 years of age and older.

Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry
Fri, 17 Sep 2021 08:31:57 EDT

  In October 2021, FDA incorporated Q2B Validation of Analytical Procedures: Methodology (May 1997)(Q2B) on methodology with the parent document Q2A Text on Validation of Analytical Procedures (March 1995)(Q2A) and retitled the combined document Q2(R1) Validation of Analytical Procedures: Text and Met

Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement - 09/17/2021 - 09/17/2021
Fri, 17 Sep 2021 07:06:23 EDT

  This is the CBER Vaccines and Related Biological Products Advisory Committee September 17, 2021 Meeting Announcement.

Berinert
Thu, 16 Sep 2021 13:09:35 EDT

  Product approval information is indicated for treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Help Stop the Spread of Coronavirus and Protect Your Family
Wed, 15 Sep 2021 11:22:22 EDT

  We can each take simple steps to slow the spread of COVID-19 and protect ourselves, our families and our communities. Get a COVID-19 vaccine. Wash your hands often. Cover your mouth and nose with a mask when around others. Avoid crowds and practice social distancing.

Janssen COVID-19 Vaccine
Wed, 15 Sep 2021 09:30:09 EDT

  Information about the Janssen COVID-19 Vaccine, manufactured by Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson

FDA Voices on Medical Products
Tue, 14 Sep 2021 09:03:18 EDT

  FDA Voices on Medical Products

Compliance Actions (Biologics)
Mon, 13 Sep 2021 10:51:52 EDT

  CBER carries out a wide range of compliance and surveillance activities during the "life cycle" of biological products





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