Federal Register notice: FDA sends to OMB an information collection revision entitled Imports and Electronic Import Entries.
Federal Register notice: FDA withdraws the approval of a Gemini Laboratories NDA for Oxandrin (oxandrolone) tablets and four ANDAs that reference the ...
FDA warns Cambridge, MD-based Safe Chain Solutions about violations of the Drug Supply Chain Security Act in its work as a wholesale drug distributor.
FDA publishes a guidance on how to present more consumer-friendly efficacy and risk information in direct-to-consumer promotional labeling and ads.
Two Oncology Center of Excellence executives describe the benefits of the new QCARD initiative intended to improve study proposals that use real-world...
Senate majority leader Chuck Schumer says FDA must develop a plan to deal with drug shortages and Congress must pursue a legislative solution to the p...
FDA publishes a draft guidance about the prohibition on wholesaling of compounded drugs under Section 503B of the Federal Food, Drug, and Cosmetic Act...
FDA issues a complete response letter on a Regeneron Pharmaceuticals BLA for Eylea (aflibercept 8 mg), a higher dose of the eye drug for treating pati...
