Sponsor Responsibilities – Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Similar Posts
Early Alert: Convenience Kit Needle Issue from Integra LifeSciences
Integra LifeSciences is removing certain lots of Microsensor and Cerelink ICP Kits with potential corrosion stains on the included Tuohy Needle.Global Generic Drug Affairs
FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumorsBiosimilars | Science and Research
Learn about FDA’s latest in biosimilar science and research.Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff.Completed BsUFA III Deliverables
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.