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FDA
Magellan Executives Charged with Conspiracy, Wire Fraud, and FDA Violations
Three former executives of Magellan Diagnostics, Inc. (Magellan) were recently charged in connection with concealing a device…
OPDP: No More Untitled Letters?
Today marks one year since the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an Untitled…
FDA Issues Draft Guidance on Dosage and Administration Labeling Section
The United States Food and Drug Administration (FDA) released draft guidance focused on improving the consistency of information…
Policy and Medicine March 2022 Issue Features FDA Exclusivity, Baby Powder,…
Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth…
Could Simplified Clinical Trials Lead to More Diversity?
During comments made at the 2023 Innovations in Regulatory Science Summit, Food and Drug Administration (FDA) Center for Drug…
2022 FDA New Drug Approvals Lowest Since 2016
In 2022, the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 37 new drugs…
Two Biotech Executives Charged in Securities Fraud Scheme
Two former executives were recently indicted for schemes to defraud investors in CytoDyn, Inc. The executives, Nader Pourhassan,…
FDA Receives Increased Budget for FY 2023
The omnibus spending bill passed by Congress in December 2023 includes funding and direction for the United States Food and Drug…
Congressional Report Released on FDA’s Improper Actions in Aduhelm Approval…
Following an 18-month investigation, House of Representatives Oversight and Reform Committee Chairwoman Carolyn Maloney and Energy…
Omnibus Bill Includes Changes to Pharmaceutical and Device Investigational…
The omnibus spending bill that passed Congress shortly before Christmas 2022 included legislation that was previously introduced…