FDA proposes excluding Novo, Lilly weight loss drugs from bulk compounding list in win for the companies

If that proposal is finalized, the exclusion would likely limit the mass compounding of those medicines ​unless they appear ...
Becker's Hospital Review

FDA proposes new framework for clinical drug trial designs

The FDA has released new draft guidance outlining the use of Bayesian methodologies in clinical trials for drugs and biologics. The guidance is intended to help sponsors apply modern statistical ...

Food and Drug Administration (FDA): What It Is and Does

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
Regulatory Affairs Professionals Society

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for antibiotics produced through fermentation or semi-synthetic methods.
JD Supra

FDA Issues Guidance to Industry in Effort to Accelerate Development and Reduce Costs of Biosimilar Drugs

The U.S. Food and Drug Administration’s (FDA) new draft guidance may reduce the cost and time to market for some applicants with biosimilar Biologic License Applications (BLAs). This draft guidance ...
Healio

FDA-identified uncertainties about new cancer drugs often omitted in journals, guidelines

Please provide your email address to receive an email when new articles are posted on . The FDA frequently identifies uncertainties about newly approved cancer drugs, but they are often omitted in ...
Health Affairs

Drug Coverage Policies And Clinical Guidelines Alignment: Most Coverage Decisions Include Additional Restrictions

Utilization management criteria influence patients’ access to specialty drugs, yet the processes used by health plans to establish these criteria are not well understood. This study examined the ...