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The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device and biologics products. Target release dates vary by rule. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) issued a seven-page untitled letter informing Xeris Pharmaceuticals that its website advertising the drug Recorlev (levoketoconazole) makes “false or misleading claims and representations about the safety and efficacy” of the tablets. Read More
FDA’s method for assessing requests for major-to-minor reclassifications for complete response (CR) letters is described in the just-released Manual of Policies and Procedures (MAPP). Read More
Drugs or indications should not “maintain approval if confirmatory studies fail, even while additional confirmatory studies are pursued,” the researchers say. Read More
Several chambers of commerce have sued HHS and CMS over the Inflation Reduction Act (IRA) claiming that the prescription drug price control program is “a violation of America’s fundamental constitutional requirements of limited government, property rights, the rule of law, and the separation of powers.” Read More
The FDA sketched out how it is implementing the fee structure of the Generic Drug User Fee Amendments of 2022 (GDUFA III) in a final guidance released Friday. Read More
The FDA should be as willing to withdraw an accelerated approval as to grant it, write a team of researchers, arguing for a balance between speed and certainty. Read More
The FDA has finalized its guidance on drug-drug interaction (DDI) studies of investigational drugs with combined oral contraceptives (COC), outlining when these studies are and aren’t needed, how to design them and how to communicate findings. Read More
The FDA will not let Intarcia choose reviewers for the upcoming Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to consider the company’s troubled diabetes drug-device product, nor will the agency grant other requests Intarcia made last month. Read More