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The agency will grant a meeting if it concerns a product for which there is no product-specific guidance or an “alternative equivalence evaluation.” Read More
HHS has formally appealed a July ruling by a federal court in Washington, D.C., which blocked the department from requiring drug companies to disclose the prices of drug prices in their direct-to-consumer TV ads. Read More
The FDA is delaying enforcement action for one year against wholesale distributors who fail to comply with certain sections of the Drug Supply Chain Security Act (DSCSA), the agency said in a new guidance released on Tuesday. Read More
The agency is providing a two-year transition period for sponsors to make changes to their manufacturing processes and to implement adequate testing methods. Read More
The filing came just days after the FDA and EMA announced they are investigating the drug after learning that it contained low levels of the impurity. Read More
The FDA urges trial sponsors who may be thinking of using Bayesian statistics in complex innovative trials to consider alternatives, in a new draft guidance issued Monday. Read More
Senior FDA officials promised “flexibility” to help address the unmet medical need as the agency released final guidance on Monday for sponsors of treatments for amyotrophic lateral sclerosis (ALS) — Lou Gehrig’s disease. Read More