FDA cracks down on sponsor and researchers’ failure to publish trial data

The European Medicines Agency (EMA) has taken a similar transparency stance with clinical trials. In October 2023, the EMA ...

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FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
Dermatology Advisor

FDA Expands Dupixent Approval to Children Aged 2 to 11 With CSU

FDA expands Dupixent approval for children aged 2 to 11 years with chronic spontaneous urticaria symptomatic despite H1 antihistamine use.
JD Supra

FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases

As discussed previously (“New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the ...
RAPS

FDA drafts guidance on animal testing alternatives

The US Food and Drug Administration (FDA) has released draft guidance aimed at assisting pharmaceutical manufacturers in transitioning from animal studies to non-animal alternatives for drug ...
The American Journal of Managed Care

FDA Guidance to Remove One of the Largest Barriers to Biosimilar Development

The FDA's draft guidance could streamline biosimilar approval by reducing the need for comparative efficacy studies, emphasizing analytical assessments instead. This approach may lower development ...
CBS News

FDA warns consumers about 19 cookware products that could leach lead into your food. Here's the list.

The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people's food. Consumers should ...
PharmTech

Pharma Fundamentals: Using Virtual Control Groups to Reduce Animal Testing in Drug Development

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of ...