From Our Perspective
Latest From Our Perspective
OMUFA – Past, Current, and Future
Over-the-Counter (OTC) drugs have long provided an efficient, low-cost way for Americans to take care of everyday health needs, without having to visit a doctor and obtain a prescription.
FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program
Dr. Patrizia Cavazzoni and Dr. Peter Marks discuss how the FDA's new START Pilot Program aims to accelerate the development of treatments for rare diseases. By offering enhanced support and guidance to selected sponsors, this initiative helps generate high-quality data and brings novel drugs and biologics to patients more efficiently.
Education Efforts to Help Increase Biosimilar Understanding and Acceptance
Sarah Ikenberry, M.A., explains the FDA's comprehensive efforts to enhance the understanding and acceptance of biosimilars among healthcare providers and the public. These educational initiatives clarify the benefits, safety, and efficacy of biosimilars, promoting their broader adoption in the U.S. healthcare system.
CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients
Sarah Ibrahim, PhD, highlights the collaborative effort between CDER’s OGD and EMA to streamline the development of complex generics. This initiative aims to harmonize regulatory approaches and provide simultaneous feedback from both agencies, facilitating the development of generic drugs that reach patients faster.