FDA warns Hiram, GA-based VasoCorp Inc. that it is illegally marketing misbranded unapproved new drugs.
The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...
FDA issues a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, I...
FDA posts 17 revised draft product-specific guidances for peptide products, which it touts as a significant advancement in the agencys scientific and ...
FDA accepts for review a Saol Therapeutics NDA resubmission for SL1009 (sodium dichloroacetate, or DCA), an investigational treatment for pyruvate deh...
FDA releases the 17-page form FDA-483 following a May inspection at Indias Strides Pharma Science drug manufacturing facility in Bangalore.
In its report on FY 2024 approvals of medical devices for pediatric uses, FDA says that 19 of the 56 device approvals that year were indicated for use...
FDA releases the form FDA-483 with three observations from an inspection at the Novel Laboratories (Lupin) drug manufacturing facility in Somerset, NJ...
