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 Roundup: June 21, 2024
Fri, 21 Jun 2024 15:11:38 EDT

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

FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review
Fri, 21 Jun 2024 10:48:57 EDT

  Following an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway.

FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
Thu, 20 Jun 2024 17:24:43 EDT

  The FDA expanded the approval of Elevidys, a gene therapy for the treatment of Duchenne muscular dystrophy for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.

FDA Roundup: June 18, 2024
Tue, 18 Jun 2024 15:16:01 EDT

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

FDA Roundup: June 14, 2024
Fri, 14 Jun 2024 15:54:06 EDT

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

Biden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle Organics
Wed, 12 Jun 2024 11:32:48 EDT

  FDA, USDA, EPA Announce National Strategy to Reduce Food Loss and Waste and Recycled Organics as part of President Biden’s whole-of-government approach to tackle climate change, feed people, and promote a circular economy.

FDA Roundup: June 11, 2024
Tue, 11 Jun 2024 15:35:22 EDT

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

Justice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-Cigarettes
Mon, 10 Jun 2024 11:51:36 EDT

  The U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.

FDA Roundup: June 7, 2024
Fri, 07 Jun 2024 15:44:46 EDT

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

FDA Roundup: June 4, 2024
Tue, 04 Jun 2024 14:27:48 EDT

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

FDA Roundup: May 31, 2024
Fri, 31 May 2024 15:21:34 EDT

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

FDA, USDA, EPA enhance efforts to reduce food loss and waste, welcome USAID to interagency collaborative
Thu, 30 May 2024 16:31:16 EDT

  FDA, USDA, EPA announce the signing of a formal agreement to renew their Federal interagency Collaboration to Reduce Food Loss and Waste (FIFLAW) and welcome USAID making a significant expansion of the federal collaboration.

FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts
Thu, 30 May 2024 11:28:26 EDT

  FDA reached a significant milestone with approval of its reorganization involving the creation of a unified HFP, adoption of a new model for its field operations and other significant modernization efforts.

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases
Tue, 28 May 2024 18:06:57 EDT

  FDA approved Bkemv as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH); and atypical hemolytic uremic syndrome (aHUS).

FDA Roundup: May 28, 2024
Tue, 28 May 2024 15:39:46 EDT

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

FDA Roundup: May 24, 2024
Fri, 24 May 2024 14:45:42 EDT

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

FDA Roundup: May 21, 2024
Tue, 21 May 2024 16:26:28 EDT

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

FDA Roundup: May 17, 2024
Fri, 17 May 2024 15:46:25 EDT

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

FDA Roundup: May 14, 2024
Tue, 14 May 2024 13:51:48 EDT

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

FDA Roundup: May 10, 2024
Fri, 10 May 2024 16:00:03 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

Totally Cool, Inc., Recalls All Ice Cream Products Because of Possible Health Risk
Mon, 24 Jun 2024 20:59:00 EDT

  Totally Cool, Inc. of Owings Mills, Maryland is recalling multiple brands of ice cream products, 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 others w

Wildly Beloved Foods is Recalling Orzo (Vegan) Dried and Campbell (Vegan) Dried Due to Potential Mold
Mon, 24 Jun 2024 20:34:00 EDT

  June 24, 2024, Wildly Beloved Foods of Clinton, Washington is recalling approximately 30 packages of Orzo (vegan) Dried and 30 packages of Campanelle (vegan) Dried, 10 oz, due to potential mold growth contamination. The recalled Orzo (vegan) Dried, 10oz were distributed through Payless Foods, The

DSD Merchandisers, LLC Announces Voluntary Recall of Deluxe Roasted & Salted Mixed Nuts Due to Undeclared Peanut
Mon, 24 Jun 2024 20:09:00 EDT

  DSD Merchandisers, LLC is voluntarily recalling UPC 6-51433-99651-6 Deluxe Roasted & Salted Mixed Nuts, Sell by: 10/09/24, due to the presence of undeclared peanut. People who have an allergy or severe sensitivity to specific type of allergen peanuts run the risk of serious or life-threatening aller

Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Mon, 24 Jun 2024 00:00:00 EDT

  Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Risk Statement: The failed dissolution of potassium chlor

Vitakraft Sun Seed Recall of Sun Seed Vita Prima Hedgehog Food Due to Possible Salmonella Health Risk
Fri, 21 Jun 2024 13:08:00 EDT

  Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling one lot of Sun Seed Vita Prima Hedgehog Food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is also a risk to humans from handling contaminated pet products,

TDBBS LLC Recalls Green Tripe Dog Treats Due to Potential Foreign Metal Object Contamination
Thu, 20 Jun 2024 00:00:00 EDT

  Richmond, Va. - TDBBS LLC is voluntarily recalling 3,551 bags of Green Tripe dog treats due to the potential presence of foreign metal objects in the dog treat. The recalled product was distributed between February to May 2024, and sold nationwide in retail stores and through online mail orders. T

Hudson Harvest Issues Voluntary Recall of Tomato Basil Sauce Due to Potential Under-Processing
Tue, 18 Jun 2024 16:55:00 EDT

  Hudson Harvest of Germantown, NY, is voluntarily recalling Hudson Harvest Tomato Basil Sauce because of reported swelling, leaking, or bursting jars. There is a possibility that the product has been under processed, which could lead to the potential for spoilage organisms or pathogens.

Snapchill LLC Recalls Canned Coffee Products Due to Potential Clostridium botulinum
Mon, 17 Jun 2024 15:08:00 EDT

  Snapchill LLC (Snapchill) of Green Bay, WI is voluntarily recalling all canned coffee products manufactured by the company, within expiration date, because their current process could lead to the growth and production of the deadly toxin, botulinum toxin, in low acid canned foods. Botulism, a poten

Villa Nueva Interservices LLC Issues Allergy Alert on Undeclared Milk in "Arepas LA Mejor" 25 oz Bags of Arepa de Choclo /Chocolo
Tue, 11 Jun 2024 17:09:00 EDT

  Villa Nueva Interservices LLC. in Lake Worth, FL is recalling "Arepas LA Mejor" 25 oz bags of Arepa de Choclo /Chocolo because it contains undeclared milk. People who have an allergy or severe sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume these pro

Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Tue, 11 Jun 2024 12:10:00 EDT

  Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 1

Penn Herb Company Ltd Recalls Nature’s Wonderland Thyroid Formula Because of Possible Health Risk
Tue, 11 Jun 2024 00:00:00 EDT

  Penn Herb Company Ltd of Philadelphia, Pennsylvania is recalling 51 bottles (60 Capsules per bottle) of Nature’s Wonderland Thyroid Formula (Item #: Sm32x, Lot #: 23289A), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infecti

Classic Delight LLC Issues Public Health Alert Due to Possible Health Risk
Mon, 10 Jun 2024 10:04:00 EDT

  Classic Delight LLC, a St. Mary’s, OH firm is voluntarily recalling a limited number of individually wrapped sandwiches due to potential contamination with Listeria monocytogenes

ADM Animal Nutrition Expands Recall to Include Additional Lots of Various Feed Products
Mon, 10 Jun 2024 00:00:00 EDT

  Specific lots may contain elevated levels of magnesium, sodium, calcium, chloride and/or phosphorus; may harm cattle, chickens, equine, goats, lambs, llamas, rabbits, sheep and swine Quincy, Ill., June 10, 2024 – ADM Animal Nutrition, a division of ADM (NYSE: ADM), is expanding the recalls announce

Green Life Farms Issues Voluntary Recall of Baby Arugula Because of Possible Health Risk
Fri, 07 Jun 2024 13:53:00 EDT

  Lake Worth, FL (June 7, 2024) – Green Life Farms is voluntarily recalling one lot of its 4-ounce containers of Baby Arugula because they have the potential to be contaminated with Salmonella. Symptoms of Salmonella may include diarrhea, fever, and abdominal cramps. Illness usually occurs within 12 t

HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination
Wed, 05 Jun 2024 18:41:00 EDT

  HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.

New Seasons Market Issues Allergy Alert on Undeclared Almonds in Strawberry Rhubarb Bakewell Tart
Tue, 04 Jun 2024 18:21:00 EDT

  June 4, 2024, New Seasons Market of Portland, Oregon is recalling Strawberry Rhubarb Bakewell Tart, because it contains undeclared almond. People who have an allergy or severe sensitivity to almond run the risk of serious or life-threatening allergic reaction if they consume this product.

UBC Food Distributors Recalls Baraka Brand Ground Black Pepper Spice Because of Possible Health Risk Announcement
Mon, 03 Jun 2024 16:29:00 EDT

  UBC Food Distributors in Dearborn Michigan is recalling the Ground Black Pepper under the Baraka brand name in 7oz plastic containers 7oz * 10 With UPC code 8 22514 26626 6 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infect

World Green Nutrition, Inc. Expands Recall of Tejocote Products Due to the Presence of Yellow Oleander
Mon, 03 Jun 2024 16:16:00 EDT

  World Green Nutrition, Inc is announcing the expansion of their April 03, 2024 recall to include more lot numbers of the products GREEN ELV NUTRITION brand Elv Control Herbal Supplement 90 capsules and ELV ALIPOTEC brand Mexican Tejocote Root Supplement Pieces (Raiz de Tejocote Mexicano Suplemento e

Dairy Manufacturers Inc. Is Notifying Consumers About a Safety Concern With Crecelac Infant 0-12 Infant Formula (Lot # 24 039 1 CHE 352-1) That is Part of an Ongoing Recall – Expansion of Previous Recall
Mon, 03 Jun 2024 12:24:00 EDT

  Dairy Manufacturers Inc., of Prosper, TX – 6/3/24, is notifying consumers about a safety issue associated with a product that is an extension of an ongoing voluntary recall (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dairy-manufacturers-inc-issues-voluntary-recall-products-d

Medline Industries, LP Issues Nationwide Recall of SubG Endotracheal Tube with Subglottic Suction
Fri, 31 May 2024 21:18:00 EDT

  On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, l

What's New: Drugs RSS Feed

Generic Drug Facilities, Sites and Organization Lists
Tue, 25 Jun 2024 09:41:26 EDT

  Generic Drug Facilities, Sites and Organization Lists

Know Which Medication Is Right for Your Seasonal Allergies
Tue, 25 Jun 2024 09:38:39 EDT

  The pollen count is sky-high. You’re sneezing, your eyes are itching, and you feel miserable. Seasonal allergies are real diseases that can interfere with your life. The FDA regulates prescription and nonprescription medications that offer allergy relief.

Competitive Generic Therapy Approvals
Tue, 25 Jun 2024 09:30:27 EDT

  A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act.

Sani-Care Salon Products, Inc. - 673747 - 04/24/2024
Tue, 25 Jun 2024 09:20:04 EDT

  CGMP/Finished Pharmaceuticals/Adulterated

Glenmark Pharmaceuticals Inc., USA Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution
Tue, 25 Jun 2024 09:03:55 EDT

  Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Risk Statement: The failed dissolution of potassium chlor

Compounding Risk Alerts
Tue, 25 Jun 2024 08:36:32 EDT

  FDA issues compounding risk alerts to communicate information to alert health care professionals to adverse events and outbreaks related to compounded drugs so that practitioners can more effectively protect patients from unsafe, ineffective, and poor quality compounded medicines.

Compounding Quality Center of Excellence Annual Conference - 09/11/2023
Mon, 24 Jun 2024 17:54:52 EDT

  Compounding Quality Center of Excellence Annual Conference

What's New Related to Drugs
Mon, 24 Jun 2024 14:04:21 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.

For Healthcare Professionals | FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems
Mon, 24 Jun 2024 13:07:43 EDT

  FDA’s Examples of Interacting Drugs and Other Substances Involving CYP Metabolic- and Transporter System-Based Pathways for Healthcare Professionals

OPDP eCTD
Mon, 24 Jun 2024 12:36:31 EDT

  The OPDP eCTD page contains all resources and reference materials produced by OPDP in support of the OPDP Electronic Submissions Guidance.

Over-The-Counter Monograph Drug User Fee Program (OMUFA)
Mon, 24 Jun 2024 12:28:29 EDT

  A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.

Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Mon, 24 Jun 2024 11:49:17 EDT

  Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 1

Statistical Considerations for Premarketing Risk Assessment - 05/16/2024
Mon, 24 Jun 2024 11:32:18 EDT

  Statistical Considerations for Premarketing Risk Assessment

Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval - 05/09/2024
Mon, 24 Jun 2024 11:25:38 EDT

  Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval

Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products - 07/11/2024
Mon, 24 Jun 2024 11:01:05 EDT

  Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic Products

Report | Drug Shortages: Root Causes and Potential Solutions
Mon, 24 Jun 2024 10:32:16 EDT

  Drug Shortages: Root Causes and Potential Solutions examines the underlying factors responsible for drug shortages and recommends enduring solutions. The report relies on information from stakeholders, published research, and economic analysis of market conditions affecting drug shortages.

Registered Outsourcing Facilities
Mon, 24 Jun 2024 10:31:42 EDT

  Compounding is generally a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individua

Notable Approvals | Drugs
Mon, 24 Jun 2024 10:08:16 EDT

  News about human drug-related approvals

FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
Mon, 24 Jun 2024 10:04:19 EDT

  FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Facilitating Generic Drug Product Development through Product-Specific Guidances - 04/25/2024
Mon, 24 Jun 2024 10:02:21 EDT

  Facilitating Generic Drug Product Development through Product-Specific Guidances

Whats New Vaccines Blood Biologics RSS Feed

Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank - 680039 - 06/10/2024
Tue, 25 Jun 2024 09:20:05 EDT

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

What’s New for Biologics
Mon, 24 Jun 2024 17:16:03 EDT

  Latest news from the Center for Biologics Evaluation and Research

Roster of the Cellular, Tissue and Gene Therapies Advisory Committee
Mon, 24 Jun 2024 15:27:12 EDT

  This is the Roster of the Cellular, Tissue and Gene Therapies Advisory Committee.

Vaccines and Related Biological Products Advisory Committee June 5, 2024 Meeting Announcement - 06/05/2024
Mon, 24 Jun 2024 14:22:44 EDT

  This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) June 5, 2024 Meeting announcement and meeting materials.

Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases
Mon, 24 Jun 2024 10:10:19 EDT

  Testing HCT/P Donors for Relevant Communicable Diseases

Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
Mon, 24 Jun 2024 10:02:21 EDT

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

Laboratory Developed Tests: Small Entity Compliance Guide
Mon, 24 Jun 2024 09:01:58 EDT

  FDA has prepared this document to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.


Jobs at the Center for Biologics Evaluation and Research (CBER)
Mon, 24 Jun 2024 08:08:03 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.

FDALabel: Full-Text Search of Drug Product Labeling
Fri, 21 Jun 2024 13:39:18 EDT

  FDALabel Database is a web-based application that allows users to perform customizable searches of a database containing over 140,000 labeling documents for FDA-approved drug products, including human and animal prescription and over-the-counter drugs, biological products, and medical devices.

Health Fraud Scams
Fri, 21 Jun 2024 12:39:11 EDT

  Learn how to spot health fraud and avoid it.

SEVENFACT
Fri, 21 Jun 2024 12:24:27 EDT

  Treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors

Approved Cellular and Gene Therapy Products
Fri, 21 Jun 2024 11:01:56 EDT

  Listing of licensed and approved products from the Office of Therapeutic Products (OTP).

Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
Fri, 21 Jun 2024 10:27:48 EDT

  Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors, CBER, biologics, guidance, industry, bloodborne, blood, pathogen, donor, test

Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use
Fri, 21 Jun 2024 10:19:36 EDT

  Guidance for Industry: Efficacy Studies to Support Marketing of Fibrin Sealant Products Manufactured for Commercial Use, Blood, CBER, Biologics

Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001
Fri, 21 Jun 2024 10:16:34 EDT

  This is the Guidance for Industry: Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001.

Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications
Fri, 21 Jun 2024 10:14:30 EDT

  This is the Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format - Biologics Marketing Applications, CBER, Biologics

PHS Guideline on Infectious Disease Issues in Xenotransplantation
Fri, 21 Jun 2024 10:03:58 EDT

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

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Fri, 21 Jun 2024 09:17:10 EDT

  Guidance for industry on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

ELEVIDYS
Thu, 20 Jun 2024 17:40:04 EDT

  Treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene.

FDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular Dystrophy
Thu, 20 Jun 2024 17:24:43 EDT

  The FDA expanded the approval of Elevidys, a gene therapy for the treatment of Duchenne muscular dystrophy for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene.





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