Abolish the FDA
It takes 10–15 years and hundreds of millions of dollars for a pharmaceutical company to navigate the Food and Drug ...
News Medical1d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Fast Track process features regular interactions with the FDA, including the potential for early and rolling review ...
After decades, FDA finally moves to pull ineffective decongestant off shelves
In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...
FiercePharma14h
GAO takes FDA to task over lagging plant inspections, recommends action plan
“FDA has not yet developed action plans to fully address travel, workload, and work-life balance because potential solutions ...
JD Supra6h
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
From AI to Musk’s brain chips, the FDA’s device unit faces rapid change
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
Researcher Sues DEA Over Marijuana Rescheduling Process
A researcher has filed a lawsuit against the Drug Enforcement Administration, accusing the agency of multiple legal ...
AZoLifeSciences on MSN12h
The Commercialization Process for Antibody Therapeutics
The rise of antibody therapeutics is transforming drug discovery, providing highly specific treatments for complex diseases ...
ConsumerAffairs7d
FDA proposes removing popular decongestant found in cold meds
The Food and Drug Administration (FDA) is proposing to officially remove a popular ingredient in many cold and allergy ...
Acsh.org14h
The Media and I: Hurricane Helene and Drug Shortages
Mark Hahn and I discuss the critical vulnerabilities in the U.S. drug supply from Hurricanes Helene and Milton.
Reuters1d
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
The drugmaker will also get the FDA's priority review voucher, which allows a drug developer to expedite the review process ...