Federal Register
FDA Seeks to Amend Radiological Health Regs
Federal Register notice: FDA proposes to amend and repeal parts of its radiological health regulations covering recommendations for radiation protecti...
Human Drugs
Warning Letters to 4 Homeopathic Drug Makers
FDA posts Warning Letters to four companies who produce homeopathic drug products, citing them for significant GMP violations.
Human Drugs
Circassia Pharma OKs sNDA for Tudorza Pressair
FDA approves a Circassia Pharmaceuticals supplemental NDA to add new data to Tudorza Pressairs (aclidinium bromide inhalation powder) prescribing info...
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FDA proposes changes to radiological health regulations to clarify and update the regulations by eliminating outdated and duplicative provisions.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...
