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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.
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...
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.
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.
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...