FDA reviewers raise concerns about the clinical evidence supporting Replimune Group's BLA resubmission for accelerated approval of its investigational...
FDA warns Woodstock, CT-based Linemaster Switch Corp. about Quality System violations in its production of medical device foot pedal accessories.
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The Pharmaceutical Research and Manufacturers of America urges FDA to revise and clarify its draft guidance on using quantitative systems pharmacology...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 encourages cancer clinical trial sponsors to adopt more flexible eligibility criteria related to washout periods and concomitant medications.
A final FDA guidance urges sponsors of cancer clinical trials to broaden laboratory value-based eligibility criteria to reduce unnecessary barriers to...
