Human Drugs
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 3/29/2019.
FDA General
Since Our Last Issue...
Industry news you may have missed since our last issue.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 3/29/2019.
Human Drugs
Daiichi Sankyo Speeding Breast Cancer BLA
Daiichi Sankyo says it is accelerating the timetable for submitting a BLA for its breast cancer drug [fam-] trastuzumab deruxtecan.
Human Drugs
Continue Clinical Trial Drug Access After Trial: FDA
Three top FDA executives urge drug companies to maintain expanded access to drugs for patients who are benefiting from them in a clinical trial after ...
Medical Devices
FDA Wants to Amend, Repeal Rad Health Regs
FDA proposes changes to radiological health regulations to clarify and update the regulations by eliminating outdated and duplicative provisions.
Human Drugs
ISMP Challenges FDA Nuplazid Evaluation
FDA and Acadia Pharmaceuticals dispute an Institute for Safe Medication Practices report questioning the safety and efficacy of Acadias Nuplazid Parki...
FDA General
FDA Office of Commissioner Reorganizing
FDA is implementing a reorganization proposed by outgoing commissioner Scott Gottlieb.
Federal Register
Vertex Gains Priority Review Voucher
Federal Register notice: FDA awards Vertex Pharmaceutical a priority review voucher after it determined that a qualified rare pediatric disease produc...
A Reflective Gottlieb Touts Drug Review Reform
Departing FDA commissioner Scott Gottlieb tells a sit-down chat session that the most enduring accomplishment at the agency during his almost two-year...
