A new draft guidance document quietly issued last week by the US Food and Drug Administration (FDA) is intended to explain how medical device manufacturers can show their devices are safe for use in ...
The Centers for Medicare and Medicaid Services (CMS) issued a final rule on the use of extrapolation to determine overpayments in risk adjustment data validation (RADV) audits of Medicare Advantage ...
The European Medicines Agency (EMA) on Friday released an updated draft reflection paper for public consultation detailing the agency's framework for pediatric extrapolation in drug development. EMA ...
The Food and Drug Administration issued a final guidance on Monday for how and when existing clinical data should be used to support pediatric medical device indications and labeling. The guidance ...
The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation ...
Some of the most widely used biologic medicines in oncology have patents about to expire, opening the market to noninnovative versions of these drugs. There are already many examples of price ...
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