Swissmedic, Switzerland’s national agency for therapeutic products, is offering a complimentary webinar on May 28, 2026.…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
FDA Grants National Priority Voucher to New Treatment for Multiple Myeloma Following Phase 3 Success
The U.S. Food and Drug Administration (FDA) has awarded a national priority voucher for teclistamab in…
FDA Removes Key Restriction on Real-World Evidence in Drug and Device Applications
The U.S. Food and Drug Administration (FDA) announced a significant regulatory update on January 12, 2026,…
FDA Strengthens Recall Processes After Infant Botulism Cases Linked to ByHeart Formula
The U.S. Food and Drug Administration (FDA) has announced plans to enhance the effectiveness of food…
FDA Seeks Venture Capital Input to Reform Contracting for Public Health Innovation
The U.S. Food and Drug Administration (FDA) is exploring new avenues for collaboration with America’s top…
FDA Recognizes Two Investigational Products with National Priority Vouchers for Affordability Breakthroughs
On January 12, 2026, the U.S. Food and Drug Administration (FDA) announced a significant milestone in…
FDA Report Highlights Data Gaps Regarding PFAS Safety in Cosmetics
The U.S. Food and Drug Administration (FDA) has released a congressionally mandated report on the safety…
FDA Eases Oversight for Cell and Gene Therapies, Encouraging Innovation
The U.S. Food and Drug Administration (FDA) has announced updates to its approach for evaluating chemistry,…
December 2025 MHRA Safety Updates: New Guidance for Medicine and Medical Device Users
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its December 2025 roundup of the…
Critical Updates: Field Safety Notices from December 22–26, 2025
The latest Field Safety Notices (FSNs) issued between December 22 and December 26, 2025, are now…