Federal Register
Several Information Collections Approved by OMB
Federal Register notice: FDA announces OMB approval of several information collections.
Human Drugs
House Passes Right-to-Try Bill
The House passes a right-to-try bill that would allow terminally ill patients access in certain circumstances to experimental therapies.
Human Drugs
FDA Analyses Help Guide Opioid Policy: Gottlieb
FDA commissioner Scott Gottlieb tells a House subcommittee that agency post-marketing analyses are helping inform opioid policy.
Medical Devices
Monteris Medical Recalls NeuroBlate System
FDA announces a Monteris Medical Class 1 recall of its NeuroBlate system and associated laser delivery probes.
Human Drugs
Five Observations at Dr. Reddy Telengana Plant
FDA releases an FDA-483 with five observations from its inspection at a Dr. Reddys API manufacturing facility in India.
Human Drugs
FDA OKs Expanded Indication for Novartis Tasigna
FDA approves an expanded indication for Novartis Tasigna (nilotinib) to include treatment of first- and second-line pediatric patients aged one year o...
Human Drugs
FDA Drug Info Mobile App Available
FDA releases its Drugs@FDA Express mobile app.
Biologics
CBER Planning 12 Guidances This Year
CBER publishes a list of 12 guidances it intends to release this calendar year.
Medical Devices
FDA Continues Warning About Magellan Diagnostics Test
FDA says that Becton Dickinson tests have demonstrated that Magellan LeadCare blood tests have a significant chance of false results when used with ve...
FDA General
House/Senate $41 Million Boost to FDA Appropriations
The House and Senate pass a fiscal year 2018 omnibus budget bill that will increase FDAs budget authority by $41 million (1.5%) over FY 2017.
