JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
JD Supra

FDA finalizes RRA manufacturing inspection guidance as US focuses on supply chain security

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...
BioSpace

FDA Struggles To Keep Lights On Amid Shutdown as Biopharmas Begin To See Delays

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in ...
InvestorsHub on MSN

Alvotech Shares Slide After FDA Requests Further Action on Simponi Biosimilar

Shares of Alvotech (NASDAQ: ALVO) fell 22% on Monday after the U.S. Food and Drug Administration (FDA) issued a Complete ...
FiercePharma

FDA looks to clarify confirmatory trial mandate for accelerated approvals

In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory trials at least be underway at the time of these conditional nods. But, after ...
Food

GAO and senators slam FDA food inspection shortfalls

FDA is under fire for missing its mandated food safety inspection goals every year since 2018 and for reducing funds for state and local food safety programs The Government Accountability Office ...

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The US Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...