fda drug approval process - Search News

FDA, accelerated approvals

BioPharma Dive · 2d

Federal watchdog cites concerns with FDA’s accelerated approval process

The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency procedures.

Becker's Hospital Review · 2d

Watchdog flags flaws in FDA's fast-track drug approvals

The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional investigations revealed at least 40. Some meeting summaries were also found to be incomplete, according to Bloomberg .

Seeking Alpha on MSN · 3d

Sarepta, Biogen drugs with accelerated approval under fire in FDA report

A report from the U.S. FDA's Office of Inspector General is calling into question the thoroughness of the agency's accelerated approval process, and is using treatments from Sarepta Therapeutics (NASDAQ:SRPT) and Biogen (NASDAQ:BIIB) as examples.

3don MSN

Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says

Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...

Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs

An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...

Business Wire4d

Simulations Plus Supported Development of Majority of FDA-Approved Drugs in 2024

SLP highlighted its impact on the pharma industry through support of the development of a majority of the drugs approved by ...

20h

Ozempic, Wegovy among drugs selected for Medicare's price negotiations

The Biden administration announced Friday that Ozempic, Wegovy and 13 additional drugs will now be covered under Medicare ...

2don MSN

Newsom Committed California to Making Its Own Insulin. It’s at Least a Year Behind His Schedule

Gov. Gavin Newsom’s ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind schedule ...

FDA Issues Draft Guidances on AI in Medical Devices, Drug Development: What Manufacturers and Sponsors Need to Know

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

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