National Review8y
Has the FDA Seen the Light on Expediting Its Drug-Approval Process?
Kamala Harris Spits Up Word Salad All Over Her Lapels Law Profs Who Can’t Cope with Decisions They Dislike What’s Trump’s Case against Harris? Psst! There Are a Handful of New Polls in ...
infectiousdiseaseadvisor.com13d
FDA Drug Approval Decisions Expected in October 2024
The PDUFA date refers to the deadline set by the US Food and Drug Administration for reviewing drug applications.
Supreme Court medication abortion case threatens ‘seismic shift’ in FDA drug approval process, experts warn
In 1962, Congress further expanded the FDA’s authority after the drug ... has created a trusted drug approval process that could be upended by a case about the medication abortion drug ...
Investopedia12d
Food and Drug Administration (FDA): What It Is and Does
FDA approval can be crucial to companies that ... U.S. Food & Drug Administration. "The Drug Development Process." U.S. Food & Drug Administration. "Inspection Basics." ...
Nature15y
2008 FDA drug approvals
However, there are some situations in which the regulatory process is considered ... potential impact on approvals of the FDA's authority to require REMS (Nature Rev. Drug Discov.
FierceBiotech4d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
Hims & Hers is selling an Ozempic knockoff without FDA approval. Here's how
In January, the FDA said it has received adverse ... Compounding is the process of customizing an approved drug by a ...
FierceBiotech9d
FDA pushed to be more open, collaborative to accelerate rare disease R&D
The FDA should be more open and collaborative to unleash a surge in approvals of rare disease drugs, according to a report by ...
Forbes10mon
FDA Approved A New Weight Loss Drug Zepbound. Here’s What To Know And Expect
which is the process of mixing or altering the ingredients of a drug. This precisely occurred with the surge and popularity of Ozempic, a GLP-1 FDA approved drug for diabetes but often prescribed ...
Public Radio Tulsa1d
No needles required: The FDA approves an at-home flu vaccine
The nasal spray option could encourage more people who have fears of doctors or needles to inoculate themselves against the ...
Neuralink Brain Implant Wins an FDA Nod to Tackle Blindness
The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain ...
FiercePharma10d
Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. | Ahead of an advisory ...