For Immediate Release: January 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA posted warning letters sent to six firms selling unapproved drugs that claim to treat …
HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “ …
Outsourcing facilities, which operate under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), may not compound a drug product that includes a bulk drug substance unless: The bulk drug substance appears on a list identifying bulk drug …
GUIDANCE DOCUMENT Draft Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Submit Comments by 04/08/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5 …
Docket Number: FDA-2007-D-0435 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Obesity and Overweight: …
Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name William and Susanne Beckett Evolution Pets LLC (b)(6) United States info@evolutionpets.com Issuing Office: Center for Veterinary Medicine United States WARNING …
Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Title Principal Veterinary Select Formula dba Allergic Pet (b)(6) United States info@allergicpet.com Issuing Office: Center for Veterinary Medicine United States WARNING …
Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name Greg Mongrain Recipient Title Vice President Intermarket Industries Inc. dba Doc Ackerman Pet Products 1131 Industrial Ave Oxnard, CA 93030 United States gmongrain@ …
Workshop | In Person Scheduled On This Page This FDA/PQRI Workshop will bring together experts from industry and senior leaders from CDER’s Office of Pharmaceutical Quality (OPQ) for interactive discussions on critical topics related to generic drug …
Docket Number: FDA-2015-D-3539 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Interim Policy on …
Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to assist you, establishments making donor eligibility (DE) determinations, in understanding the requirements in 21 CFR part 1271, subpart C …
Submit Comments by 04/07/2025 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …
Docket Number: FDA-2022-D-0465 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA or Agency, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the …
Docket Number: FDA-2022-D-0466 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA or Agency, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the …
Docket Number: FDA-2024-D-3067 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the requirements in …
Docket Number: FDA-2022-D-0464 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, in understanding the requirements in …
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued draft guidance to provide recommendations on the use of artificial intelligence (AI) intended to support a regulatory decision about a drug or biological product’s …
FDA News Release Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug …
GUIDANCE DOCUMENT Draft Level 1 Guidance Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only. Submit Comments by 04/07/2025 Although you can comment on any guidance at any time (see 21 …
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important devices for patient care that are used to estimate the …
