Republican launches investigation into Trump admin FDA denials

"The stories are so outrageous," Senator Ron Johnson said. "It just appears that they’re looking for excuses to say no." ...
STAT

FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad

FDA Commissioner Marty Makary defended the agency’s recent rejections of rare disease drugs and one of his deputies, Vinay ...

Key US senator investigates FDA over rare-disease drug denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of ...
Yahoo

Extended interview: FDA chief calls warnings on menopause treatments an "American tragedy"

Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Dr. Marty Makary tells CBS News' Norah O'Donnell in an exclusive interview why the agency decided to drop decades ...

FDA official calls UniQure's gene therapy a 'failed' treatment for Huntington's disease

UniQure needs to run another trial to prove its gene therapy "actually helps people with Huntington's disease," said a senior FDA official.

FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

FDA goes on offense amid surge of criticism for recent drug decisions

In a highly unusual move for a normally buttoned-up regulatory agency, a senior official with the US Food and Drug Administration held a call with reporters Thursday to defend the agency’s recent ...
Applied Clinical Trials Online

FDA Support Drives Shift Toward Bayesian Trial Design

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...
Targeted Oncology

Key Considerations for the FDA’s Guidance on MRD End Point in Myeloma

In an interview, C. Ola Landgren, MD, PhD, delved into the details of the FDA's draft guidance on using MRD as a basis for ...

FDA Push for Nonprescription Drugs Risks Cost Shift to Consumers

The FDA’s call to industry to shift more prescription medications to over-the-counter stands to threaten drug coverage for patients as nonprescription products are generally excluded from health plans ...
BioSpace

FDA’s One Trial Policy Not a Revolution but a Potentially Risky Evolution

Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been ...
BioSpace

FDA’s Prasad To Depart FDA Following Tumultuous Term as CBER Chief

Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle ...