Labeling and Promotion Guidances
Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.Safety...Increased Rates of Purpureocillium lilacinum Mold among Laboratory Culture Results, United States
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (D.J....Publications from Office of Biostatistics Staff
The Office of Biostatistics (OB) conducts independent research on statistical methodologies relevant to CDER’s scientific mission and regulatory review process for publication. OB research spans such broad areas as clinical trial design, Bayesian statistics, signal...Olympus Issues Voluntary Recall for Specific Lots of ViziShot 2 FLEX (19G) EBUS -TBNA Needles
Summary Company Announcement Date: September 19, 2025 FDA Publish Date: September 22, 2025 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Device Components May Detach During Procedures Company Name: Olympus Corporation Brand Name:...Malaria: Developing Drugs for Treatment
Docket Number: FDA-2025-D-0918 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for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Malaria: Developing Drugs for...Aquastar (USA) Corp Recalls Kroger Frozen Raw EZ Peel, Kroger Mercado Frozen Cooked Shrimp, and Aquastar Raw Shrimp Skewers Because of Possible Health Risk
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 21, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Due to possible radionuclide (Cesium-137) contamination Company...Western United Fish Company Recalls Kirkland Signature Brand Ahi Tuna Wasabi Poke Because of Possible Health Risk
Summary Company Announcement Date: September 20, 2025 FDA Publish Date: September 20, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Product has the potential to be contaminated with Listeria monocytogenes...MIDD Paired Meeting Program Frequently Asked Questions
Frequently Asked Questions (FAQs)What is the right time for a drug developer/sponsor to apply for MIDD?MIDD approaches can add value throughout drug development; therefore, sponsors/developers can submit a request at any time during development. A drug...Click To Verify Security & Validation
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