The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare ...

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

The integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening the ...

Generative AI, once seen as a tool for writers and artists, is now reshaping the high-stakes world of pharma regulation.

Through the Prescription Drug User Fee Act, enacted in 1992 and most recently renewed in 2012, the U.S. Food and Drug Administration can collect user fees from pharmaceutical and biological product ...

Regulators sent about 100 warning letters this week to drug advertisers, including to Hims & Hers, a major online provider of ...

The Food and Drug Administration should eliminate its approve/disapprove method of reviewing new drug applications and instead use a Consumer Reports approach that is based on drug ratings, according ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

The amendments will also enable the central drug regulator—Central Drugs Standard Control Organisation (CDSCO)—to optimise ...