FDA Announces Plan To Shorten Drug Review Time In Voucher Program
FDA announced today that it is starting a program where the FDA commissioner can provide vouchers to drug companies to shorten the review time for a New Drug Application to as little as one or two months, cutting up to a year off the regular review period. The commissioner’s National Priority Voucher or CNPV program […]
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FDA Sends Warning Letter To Sprout Pharma For Social Media Post
Last week, FDA sent a warning letter to Sprout Pharmaceuticals, Inc. for a social media post that promoted ADDYI or flibanserin. The Instagram post discussed Addy’s benefits but did not mention important safety information and related details for the target population. The agency said the CEO Cindy Eckert, shared a People magazine screenshot where a […]
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Sun Pharmaceutical Industries Receives 8-Item 483
Sun Pharmaceutical Industries Limited received an eight-item 483 after a June 2 to 13, 2025 cGMP inspection. The inspection was conducted at the firm’s Halol facility in Gujarat, India. The Halol facility is one of Sun Pharma’s largest facilities and has had regulatory issues before. The last inspection was in May 2022 and it is […]
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FDA Intends to Increase Unannounced Audits of Foreign Manufacturing Facilities
FDA announced last month that it will increase the number of unannounced cGMP inspections at foreign manufacturing plans that produce essential medicines and other medical products intended for the US market. The announcement came a few days after President Trump issued an executive order telling the FDA to give regulatory relief to increase domestic production […]
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Recent FDA Warning Letter Notes Validation Failures for Aseptic and Sterilization Processes
The May 7, 2025 warning letter to Excelvision Fareva noted several departures from cGMP guidelines. One of them was: ‘Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR […]
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FDA Issued More Warning Letters in FY2023
In fiscal year 2023, FDA issued more warning letters than the year before. The agency issued 180 warning letters to drug and biologics companies, with 95 based on on-site audits. This was a rise from 165 warning letters in FY2022, with 74 audit-based. This increase in warning letters is a return to normal FDA operations […]
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CTK OTC Labs Hit With FDA Warning Letter For Not Conducting Batch Failure Investigations
FDA sent a warning letter to CTK OTC Labs, located in Corona, California, in June 2025 for not conducting thorough investigations into batch failures related to its manufacturing of topical creams and sunscreens. FDA investigators stated that CTK OTC Labs didn’t conduct sufficient investigations of out-of-specification (OOS) results for batches which had low potency values […]
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FDA Slams Huangshi Hygienic Material Medicine in Warning Letter
Huangshi Hygienic Material Medicine Co., a maker of OTC drugs in Huangshi City, China, received a warning letter in June 2025 for various cGMP violations. One of the most critical was failure to test products before their release (21 CFR 211.165(a)) as well as failing to affix the current expiration dates on products. FDA states […]
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New FDA AI Tool, Pushed by DOGE and Trump, Isn’t Going Well
Under pressure from the Trump Administration, FDA rolled out its artificial intelligence (AI) tool this week ahead of schedule, despite a 4% budget cut for FY 2025. The large language model (LLM) named Elsa, which was billed as a tool for FDA workers, is being criticized as buggy, overhyped, and inaccurate. An NBC report yesterday […]
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FDA Launches Widely-Anticipated AI Tool To Aid Scientific Reviewers and Investigators
It’s been a long time coming. Yesterday, FDA launched Elsa, an AI tool promised to help FDA employees work with greater efficiency. FDA says the tool will modernize various FDA functions and leverage AI capabilities to improve the drug and medical device improvement process. Elsa was built in a high-security cloud environment, offering a secure […]
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