Domestic Generic Drug Fast-Track Review Program aims to expedite approval for drugs made from domestic materials.
Browsing: Regulatory & Approvals
Regulatory updates, drug approvals, submissions, and compliance developments from authorities like FDA, EMA, and others.
Generic mifepristone approval by FDA expands access to abortion care, offering a new option for patients.
FDA warning letters target misleading advertising by Novo Nordisk, Eli Lilly, and Hims, urging improved transparency and compliance.
FDA approves Forzinity for Barth syndrome, affecting 150 people in the U.S., after months of regulatory uncertainty.
Precigen FDA approval for Papzimeos granted without confirmatory trial, benefiting adult patients with recurrent respiratory papillomatosis.
FDA guidance non-opioid pain medicines includes speedy approval pathways to address the opioid crisis with new drug options.
Sun Pharma Halol Plant faces an FDA export ban due to ongoing safety violations, affecting drug exports to the US.
FDA rejection letters will be released soon after issuance, enhancing transparency in the drug review process.
FDA foreign inspections increase, targeting drug manufacturers without notice, as Commissioner Makary outlines new strategy.
Amneal FDA warning highlights use of contaminated bags in sterile injectable drugs, impacting quality control.