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FDA Warning Letters Explained: An Opportunity, Not A Threat - Life Sciences, Biotechnology & Nanotechnology

Receiving a Warning Letter from FDA can seem daunting for any company regulated by FDA, including those offering food, drug, biologic, medical device and cosmetic products. ....

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FDA Issues Second Warning Letter Of 2023 Over Potentially Misleading Efficacy Claims Regarding Inhaler - Life Sciences, Biotechnology & Nanotechnology

On August 15, 2023, the U.S. Food and Drug Administration (FDA) published a warning letter to AstraZeneca Pharmaceuticals LP, alleging that a professional sales brochure. ....

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Latest FDA Guidance Includes Minor Procedural Updates To Q-Subs For Medical Devices - Life Sciences, Biotechnology & Nanotechnology

On June 2, 2023, the FDA issued its most recent guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. ....

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CMS Issues Initial Guidance On Medicare Drug Price Negotiation Program - Healthcare

On March 15, 2023, the Centers for Medicare and Medicaid Services (CMS) issued a 91-page guidance document outlining its plans for implementing the Drug Price Negotiation Program. ....

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FDA Issues Guidance On Compounding Animal Drugs From Bulk Drug Substances - Life Sciences, Biotechnology & Nanotechnology

On April 13, 2022, the FDA issued Guidance for Industry #256 about the enforcement policy regarding the compounding of animal drugs from bulk drug substances by. ....

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