Downloads
Title
Source name
Date

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development - 05/29/2024

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development

FDA orangebook
25 Apr 2024

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

FDA orangebook
25 Apr 2024

April 24, 2024

Today, the FDA approved a new treatment for female adults with uncomplicated urinary tract infections caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

FDA orangebook
24 Apr 2024

DeRoyal Industries, Inc. Recalls Tracecarts Containing 16FR Urine Meter Foley Under Recall by Nurse Assist

DeRoyal is recalling Surgical Tracecarts with Nurse Assist 16FR Silver Urine Meter Foley due to sterility concerns. Other items in the tracecart are unaffected.

FDA orangebook
24 Apr 2024

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials

Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, CBER, Biiologics

FDA orangebook
24 Apr 2024

Considerations for Plasmid DNA Vaccines for Infectious Disease Indications

Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications, final, vaccines

FDA orangebook
24 Apr 2024

Collection of Platelets by Automated Methods

This guidance provides you, blood establishments, and FDA staff with revised recommendations for the collection of Platelets by automated methods (plateletpheresis).

FDA orangebook
24 Apr 2024

FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refra

FDA orangebook
24 Apr 2024

2023 Warning Letters - Health Fraud

2023 Warning Letters - Health Fraud

FDA orangebook
24 Apr 2024

2022 Warning Letters - Health Fraud

2022 Warning Letters - Health Fraud

FDA orangebook
24 Apr 2024

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and o

FDA orangebook
24 Apr 2024

FDA Roundup: April 23, 2024

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

FDA orangebook
24 Apr 2024

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced that it i

FDA orangebook
24 Apr 2024

April 23, 2024

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

FDA orangebook
24 Apr 2024

STOP CLOPEZ CORP Issues Voluntary Worldwide Recall of Schwinnng Capsules Due to the Presence of Undeclared Nortadalafil

Hollywood, FL, US, STOP CLOPEZ CORP is voluntarily recalling one lot of Schwinnng capsules to the consumer level. FDA analysis has found the Schwinnng products to contain Nortadalafil. Nortadalafil is

FDA orangebook
23 Apr 2024

OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites - 06/13/2024

OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites

FDA orangebook
23 Apr 2024
FDA orangebook
23 Apr 2024

Zen Enterprises LLC - 678407 - 04/18/2024

Failure to Register and List

FDA orangebook
23 Apr 2024

Reflections on Travel to Europe – Part Three

I recently had the privilege of official travel to the European Union with our global affairs team.

FDA orangebook
23 Apr 2024

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

On April 22, 2024, the Food and Drug Administration approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unrespon

FDA orangebook
23 Apr 2024

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

FDA orangebook
23 Apr 2024

2024 Compounding Quality Center of Excellence Annual Conference - 08/21/2024

The FDA Compounding Quality Center of Excellence will host its fifth Annual Conference, Aug. 21-23. This hybrid event provides an opportunity for outsourcing facilities and others to learn and build n

FDA orangebook
23 Apr 2024

United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128

The purpose of this document is to provide guidance on labeling requirements in the US for blood and blood components.

FDA orangebook
22 Apr 2024

Reflections on Travel to Europe – Part Two

I recently had the privilege of official travel to the U.K. with our global affairs team.

FDA orangebook
22 Apr 2024

FDA Encourages the Public to Follow Established Choking Rescue Protocols: FDA Safety Communication

These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.

FDA orangebook
22 Apr 2024
We use cookies to enhance your browsing experience. By continuing to use our website you agree to our policies Read the policyAccept