Regulatory Submissions with Real-World Evidence: Successes, Challenges, and Lessons Learned – 09/23/2025

DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and to improve pregnancy and lactation-related information in product labeling.

CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.

Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. To help educate patients about FDA’s rigorous review process, the economics of pricing, and related issues, FDA offers a range of educational materials, including videos, graphics, fact sheets,.

P. East Trading Corp. of Bronx, NY is recalling Salted Smoked Split Herring because the product was found to be over 5″ in length and uneviscerated, as such having potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumer

Abbott Medical is removing power cords associated with the HeartMate Mobile Power Unit due to a potential risk of the cord not locking into place.

CGMP/Finished Pharmaceuticals/Adulterated