Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Title President Energetic Essences, LLC dba Pet Essences (b)(6) United States help@petessences.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@ …
Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name Stephanie Schenk HDFrenchies LLC dba Bully Baum (b)(6) United States bullybaum@gmail.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
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 …
For Immediate Release: January 06, 2025 Today, the U.S. Food and Drug Administration issued a draft guidance with the Office for Human Research Protections that, when finalized, will provide recommendations for including tissue biopsies as part of clinical …
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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online …
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-2024-D-3334 Issued by: Guidance Issuing Office Oncology Center of Excellence For drugs granted accelerated approval, sponsors have been required to conduct confirmatory studies postapproval to verify and describe the anticipated effect …
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-2022-D-0467 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 …
