Barcode Five Rights System



Use Barcode to prevent medication errors



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 Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs
Mon, 27 Jun 2022 10:12:01 EDT

  Today, the FDA issued a proposal to broaden the range of marketed nonprescription drugs available to consumers.

FDA Infant Formula Update: June 27, 2022
Mon, 27 Jun 2022 09:14:12 EDT

  FDA Infant Formula Update June 27 Bellamy (Australia)

FDA Roundup: June 24, 2022
Fri, 24 Jun 2022 15:53:24 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Releases Action Plan for Rare Neurodegenerative Diseases, Including ALS
Thu, 23 Jun 2022 11:37:43 EDT

  The FDA launched the Action Plan for Rare Neurodegenerative Diseases including ALS, outlining the agency’s strategy for improving and extending the lives of people living with these diseases by advancing the development of safe, effective medical products, and by facilitating patient access to novel

FDA Denies Authorization to Market JUUL Products
Thu, 23 Jun 2022 10:27:56 EDT

  Today, the U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products.

FDA Infant Formula Update: June 22, 2022
Wed, 22 Jun 2022 15:30:40 EDT

  FDA exercises enforcement discretion to Global Kosher to import various Kendamil infant formula products from United Kingdom following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history

FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula
Wed, 22 Jun 2022 14:35:30 EDT

  FDA is providing an update on steps it has taken and will take to ensure safe and nutritious infant formula

FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products
Tue, 21 Jun 2022 18:30:21 EDT

  The Biden-Harris Administration published plans for future potential regulatory actions that include the FDA’s plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.

FDA Roundup: June 21, 2022
Tue, 21 Jun 2022 14:56:34 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Infant Formula Update: June 17, 2022
Fri, 17 Jun 2022 17:51:29 EDT

  FDA exercises enforcement discretion to Danone to import Aptamil infant formula products from Ireland following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.

FDA Roundup: June 17, 2022
Fri, 17 Jun 2022 16:09:47 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
Fri, 17 Jun 2022 08:52:09 EDT

  The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

FDA Infant Formula Update: June 15, 2022
Wed, 15 Jun 2022 15:27:11 EDT

  FDA exercises enforcement discretion to Mead Johnson Nutrition/Reckitt to import Enfamil Stage 1 infant formula products from Singapore following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.

FDA Roundup: June 14, 2022
Tue, 14 Jun 2022 13:15:33 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Approves First Systemic Treatment for Alopecia Areata
Mon, 13 Jun 2022 15:03:25 EDT

  The FDA approved a treatment for adults with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.

FDA Roundup: June 10, 2022
Fri, 10 Jun 2022 13:57:19 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

FDA Infant Formula Update: June 10, 2022
Fri, 10 Jun 2022 12:59:27 EDT

  FDA exercises enforcement discretion to Abbott to import various Similac infant formula products from Spain following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.

FDA Infant Formula Update: June 9, 2022
Thu, 09 Jun 2022 15:12:39 EDT

  FDA exercises enforcement discretion to Nestlé to import NAN Expert Pro Sensi Pro infant formula from Germany following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.

FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth
Wed, 08 Jun 2022 10:40:44 EDT

  The FDA launches youth e-cigarette prevention campaign, "Next Legends," to educate American Indian/Alaska Native (AI/AN) youth about the harms of vaping.

FDA Roundup: June 7, 2022
Tue, 07 Jun 2022 15:25:13 EDT

  The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

Food and Drugs Administration--Recalls/Safety Alerts

Blount Fine Foods Voluntarily Recalls a Limited Amount (a Single Lot) of Southwest Corn Chowder Due to Undeclared Wheat Allergen
Fri, 24 Jun 2022 00:00:00 EDT

  Blount Fine Foods announced that it is voluntarily recalling a limited amount (a single lot—2,569 cases total) of 16 oz. Panera at Home Southwest Corn Chowder due to an undeclared wheat allergen. The recall is limited to 1 SKU of 16 oz. Panera at Home Southwest Corn Chowder cups produced with lot nu

Daily Harvest Issues Voluntary Recall of French Lentil + Leek Crumbles Due to Potential Health Risk
Thu, 23 Jun 2022 21:18:00 EDT

  Daily Harvest has voluntarily recalled all French Lentil + Leek Crumbles due to consumer reports of gastrointestinal illness and potential liver function issues.

BD Announces Voluntary Recall on Intraosseous Products
Wed, 22 Jun 2022 18:42:00 EDT

  BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers.

Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
Wed, 22 Jun 2022 16:44:00 EDT

  Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.

Deskins Candies Recalls Peanut Butter Fudge, Peanut Butter No Bake, Chocolate No Bake, and Peanut Butter Pinwheel Because of Possible Health Risk
Tue, 21 Jun 2022 13:16:00 EDT

  Deskins Candies of Bluefield, WV is recalling the following 16 oz products: Deskins Candies Peanut Butter Fudge, Deskins Candies Peanut Butter No-Bake, Deskins Candies Peanut Butter Pinwheel, and Deskins Candies Chocolate No-Bake because it has the potential to be contaminated with Salmonella, an or

Freshpet Voluntarily Recalls One Lot of Freshpet Select Fresh from the Kitchen Home Cooked Chicken Recipe 4.5-Pound Bags Due to Potential Salmonella Contamination
Fri, 17 Jun 2022 00:00:00 EDT

  Freshpet Inc. is announcing a voluntary recall of a single lot of Freshpet Select Fresh From the Kitchen Home Cooked Chicken Recipe (4.5 lb. bag), with sell by date of 10/29/22, due to potential contamination with Salmonella

888 Food Company Issues Allergy Alert On Undeclared Egg In Various Ho King and Giai Phat Products
Wed, 15 Jun 2022 12:50:00 EDT

  888 Food Company in S. El Monte, CA is recalling Ho King Fish Ball, Ho King Fried Fish ball, Giai Phat Fried Fish Loaf, Giai Phat Fried Fish Cake, Giai Phat Fish Ball, Giai Phat Fried Fish Ball, Giai Phat Featherback Fish Ball, Giai Phat Fried Featherback Fish Ball, Giai Phat Shrimp Ball, and Giai P

Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone
Fri, 10 Jun 2022 00:00:00 EDT

  Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level.

Built Brands Voluntarily Recalls "Banana Cream Pie Puffs" Protein Bar Because of a Possible Health Risk
Fri, 10 Jun 2022 00:00:00 EDT

  Built Brands, LLC. of American Fork, UT, is recalling 4,196 individual bars of its “Banana Cream Pie Puffs” protein bar because they have the potential to be contaminated with pathogenic Escherichia coli. Although the exact strain has yet to be determined customers must not eat this product as it ma

Gourmondo Cafes and Catering Co. Issues Allergy Alert on Undeclared Egg in Asparagus and Feta Sandwich
Thu, 09 Jun 2022 00:00:00 EDT

  Gourmondo Co. of Seattle, WA is recalling “Asparagus & Feta Sandwiches” Net Weight 11.04 oz / 313 g with best bv dates of 6/5 and 6/7, due to undeclared egg (allergen). People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consu

Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination
Thu, 09 Jun 2022 00:00:00 EDT

  Camarillo, California, Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. This microorganism is rarely as

Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination
Wed, 08 Jun 2022 00:00:00 EDT

  Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL

Prairie City Bakery Recalls Peanut Butter Chocolate Chip Ooey Gooey Butter Cakes Because of Possible Health Risk
Wed, 08 Jun 2022 00:00:00 EDT

  Prairie City Bakery of Vernon Hills, IL is voluntarily recalling select lots of Prairie City Bakery® Peanut Butter Chocolate Chip Ooey Gooey Butter Cake. The product contains Jif® peanut butter that was voluntarily recalled by the J.M. Smucker company on May 20, 2022, due to the potential for Salmon

F&S Fresh Foods Recalls 7.25oz Garden Highway Snacks Brand Protein Power Snack (UPC 8 26766 00979 4) Because of Possible Health Risk
Tue, 07 Jun 2022 16:16:00 EDT

  F&S Produce Co of Vineland, NJ is recalling a limited quantity of Protein Power Snack, because it contains a cup of 0.75oz JIF peanut butter which has the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or e

Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination
Tue, 07 Jun 2022 00:00:00 EDT

  Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.

Taharka Brothers Ice Cream Recalls Peanut Butter Cup Ice Cream Because of Possible Health Risk
Mon, 06 Jun 2022 00:00:00 EDT

  Taharka Brothers Ice Cream of Baltimore, Maryland is recalling its Peanut Butter Cup ice cream, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened imm

Irvington Seafood Recalls “Crabmeat: Jumbo, Lump, Finger, and Claw Meat” Because of Possible Health Risk
Thu, 02 Jun 2022 00:00:00 EDT

  Irvington Seafood of Irvington, AL, is recalling its 1 lb. packages of "Crabmeat: Jumbo, Lump, Finger, and Claw meat" because they have the potential to be contaminated with Listeria monocytogenes

Wilton Brands Issues Allergy Alert on Possible Presence of Undeclared Milk in Two Sprinkle Products
Thu, 02 Jun 2022 00:00:00 EDT

  Wilton Industries, Inc. of Naperville, Illinois is initiating a voluntary national recall of select lots of Rainbow Chip Crunch Sprinkles And Rainbow Sprinkles Mix. Although the product label does indicate that it may contain milk, this recall is being conducted because some samples of the product

Baxter Issues Urgent Medical Device Correction to Reinforce Important Safety Information Regarding Possible Risk of Oxygen Desaturation While Using Volara Device in Line With Ventilator in a Home Care Environment
Wed, 01 Jun 2022 15:34:00 EDT

  Deerfield, Ill. – 2022-06-01 - Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Volara System (home care) to reinforce important safety information regarding a possible risk of decrease in oxygen levels (oxygen desaturation) or injury that may resul

Paris Brothers Inc. Voluntary Limited Recall
Wed, 01 Jun 2022 13:34:00 EDT

  Paris Brothers, Inc., of Kansas City, Missouri is recalling several specific cheese products listed below because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and

What's New: Drugs RSS Feed

FDA’s Labeling Resources for Human Prescription Drugs
Tue, 28 Jun 2022 00:04:22 EDT

  FDA’s Labeling Resources for Human Prescription Drugs

CDER SBIA Chronicles
Mon, 27 Jun 2022 17:45:11 EDT

  FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

An FDA Self-Audit of Continuous Manufacturing for Drug Products | Audio Transcript
Mon, 27 Jun 2022 17:43:16 EDT

  Preparation is key when managing drug product recalls. It is critical for firms to be “recall ready” so that they can act quickly and effectively to protect the public from violative products on the market.

Compounding: Inspections, Recalls, and other Actions
Mon, 27 Jun 2022 14:44:55 EDT

  Human drug compounding; FDA inspections; compounding recalls

Nonprescription Drugs Advisory Committee Roster
Mon, 27 Jun 2022 14:14:41 EDT

  This page contains the Nonprescription Drugs Advisory Committee Roster, which lists the current members and the current number of vacancies for the committee.

Over-the-Counter OTC | Nonprescription Drugs
Mon, 27 Jun 2022 14:01:16 EDT

  Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process.

Drug Safety Oversight Board Meetings - Public Summaries
Mon, 27 Jun 2022 13:23:37 EDT

  This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and discussed with the Board. Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or Inst.

Ongoing | Cancer Accelerated Approvals
Mon, 27 Jun 2022 11:24:30 EDT

  This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit.

Generic Drug Facilities, Sites and Organization Lists
Mon, 27 Jun 2022 11:21:17 EDT

  Generic Drug Facilities, Sites and Organization Lists

The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
Mon, 27 Jun 2022 11:09:27 EDT

  The FDA is announcing the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an additional conditi

Consumer Updates
Mon, 27 Jun 2022 11:06:26 EDT

  Science-based health and safety information you can trust.

What's New Related to Drugs
Mon, 27 Jun 2022 10:54:49 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.

FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma
Mon, 27 Jun 2022 10:47:25 EDT

  FDA approves lisocabtagene maraleucel for second-line treatment of large B-cell lymphoma

Drugs
Mon, 27 Jun 2022 10:37:44 EDT

  Consumer articles about over-the-counter and prescription drugs.

Oncology (Cancer) / Hematologic Malignancies Approval Notifications
Mon, 27 Jun 2022 10:29:41 EDT

  Oncology (Cancer) / Hematologic Malignancies Approval Notifications

Office of New Drugs (OND) | Annual Reports
Mon, 27 Jun 2022 10:12:20 EDT

  This report offers readers insight into OND’s priorities through a message from the Director.

FDA approves treatment for chronic weight management in pediatric patients aged 12 years and older
Mon, 27 Jun 2022 09:26:43 EDT

  The U.S. Food and Drug Administration has approved a supplemental indication for Qsymia (phentermine and topiramate extended-release capsules) for chronic weight management in pediatric patients aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater w

FDA approves treatment for weight management in patients with Bardet-Biedl Syndrome aged 6 or older
Fri, 24 Jun 2022 14:28:59 EDT

  The U.S. Food and Drug Administration has approved a supplemental indication for Imcivree (setmelanotide) injection for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Imcivree is the first drug approved specifically

User Fee Lists
Fri, 24 Jun 2022 14:07:33 EDT

  Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
Fri, 24 Jun 2022 13:00:10 EDT

  Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

Whats New Vaccines Blood Biologics RSS Feed

Blood Grouping Reagents - ORTHO Sera, ALBAclone
Mon, 27 Jun 2022 20:44:16 EDT

  Product approval information is indicated for:
•ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).
•ORTHO Sera Anti-D (IAT) is for the in vitro detection of human Rh D positive red blood cells by the indirect antiglobulin test.
•ORTHO Sera Anti-Lea is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-Leb is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
•ORTHO Sera Anti-N is for the qualitative in vitro detection of human N positive red blood cells by the direct agglutination test.

What’s New for Biologics
Mon, 27 Jun 2022 20:02:58 EDT

  Latest news from the Center for Biologics Evaluation and Research

Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement - 06/29/2022
Mon, 27 Jun 2022 15:35:00 EDT

  This is the CBER Cellular, Tissue, and Gene Therapies Advisory Committee June 29-30, 2022 Meeting Announcement.

Biologics Electronic Reading Room (eFOI)
Mon, 27 Jun 2022 12:42:58 EDT

  The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site.

Consumer Updates
Mon, 27 Jun 2022 11:06:26 EDT

  Science-based health and safety information you can trust.

Jobs at the Center for Biologics Evaluation and Research (CBER)
Mon, 27 Jun 2022 10:56:34 EDT

  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.

Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement - 06/28/2022
Sat, 25 Jun 2022 11:44:27 EDT

  This is the main page for the CBER Vaccines and Related Biological Products Advisory Committee June 28, 2022 Meeting Announcement.

Administrative Guidances
Fri, 24 Jun 2022 14:55:48 EDT

  This page lists Administrative Guidance documents.

RegenMedEd Webinar: The Critical Role of Patients in Advancing Gene Therapy Treatments for Rare Diseases - 03/09/2022
Fri, 24 Jun 2022 14:48:43 EDT

  The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) is hosting a public webinar on Wednesday, March 9, 2022, from 11:00 a.m. - 12:00 p.m. ET.

Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates - 05/06/2021
Fri, 24 Jun 2022 14:37:10 EDT

  FDA is hosting a patient workshop on May 6, 2021. This workshop will bring together patients, caregivers, advocates, and other important stakeholders to discuss ways for patients and their advocates to work with FDA to help advance regenerative medicine for rare and genetic diseases.

OTAT Learn
Fri, 24 Jun 2022 14:07:19 EDT

  Welcome to OTAT Learn (Office of Tissues and Advanced Therapies; previously OCTGT Learn), the Center for Biologics, Evaluation and Research's (CBER) web page for industry education.

Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates - 05/24/2022
Fri, 24 Jun 2022 13:42:00 EDT

  New event page to promote CBER's annual patient engagement and regenerative medicine workshop. The webpage will include information about the event, including the agenda and event details. We would like the event to be featured here: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops

MP Diagnostics HTLV Blot 2.4
Fri, 24 Jun 2022 11:12:33 EDT

  Product approval information for detection of antibodies to HTLV-I (anti-HTLV-I) and/ or antibodies to HTLV-II (anti-HTLV-II) in human serum and plasma specimens.

Lot Distribution Database (LDD)
Fri, 24 Jun 2022 11:08:40 EDT

  Lot Distribution Database (LDD)

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Fri, 24 Jun 2022 08:45:02 EDT

  Electronic Submissions

Workshops, Meetings & Conferences (Biologics)
Thu, 23 Jun 2022 16:08:49 EDT

  Information on CBER sponsored or co-sponsored meetings, conferences and workshops about various biologics in order to educate the public and seek the opinion of interested parties.

CBER-Regulated Products: Shortages and Discontinuations
Thu, 23 Jun 2022 16:03:49 EDT

  A CBER-regulated product shortage occurs when a CBER-regulated product is not commercially available in sufficient quantity to meet the demand.

Science and Regulation of Bacteriophage Therapy Workshop - 08/30/2021
Thu, 23 Jun 2022 16:02:57 EDT

  The Food and Drug Administration, Center for Biologics Evaluation and Research; and the National Institutes of Health, National Institute of Allergy and Infectious Diseases are announcing a public workshop entitled “Science and Regulation of Bacteriophage Therapy.”

Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
Thu, 23 Jun 2022 14:38:46 EDT

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

PHS Guideline on Infectious Disease Issues in Xenotransplantation
Thu, 23 Jun 2022 14:31:56 EDT

  This is the PHS Guideline on Infectious Disease Issues in Xenotransplantation, CBER, Biologics





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