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FDA

From FDA - Page 12
Abbreviated program aims to facilitate evolutionary medical devices to benefit patients. Agency seeks comment on the draft guidance by July 11.
FDA Offers Option for 510(k) Clearance
Kratom Capsules / Image: Mary Esch
FDA Forces Unprecedented Mandatory Recall of Kratom Products
Commissioner Scott Gottlieb’s announcement takes a step forward in implementing DQSA and section 503B; directs agency to develop 503B bulks list.
FDA Statement Addresses Drug Compounding and Outsourcing Facilities
Agency issues warning letters to Olympus, Fujifilm and Pentax for failure to comply with required postmarket surveillance studies to assess contamination risk.
FDA Warns Duodenoscope Manufacturers for Compliance Failures
FDA's goal is to help sponsors avoid contributing to medication errors, encouraging public comment by May 11, 2018.
New Draft Guidance Issued for Animal Drug Names
The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.
FDA's Draft Guidance on Label Highlights Section
Heparin
Congress Asks FDA to Investigate Heparin Supply
Though not a mandate, FDA Commissioner Gottlieb recognizes that blister packaging could help alleviate addiction, abuse and overdosing of medications such as opioids and loperamide.
Can unit-dose packaging reduce opioid abuse?
Though not a mandate, FDA Commissioner Gottlieb recognizes that blister packaging could help alleviate addiction, abuse and overdosing of medications such as opioids and loperamide.
Can Unit-Dose Packaging Reduce Opioid Abuse?
Stem Cell Producer / Image: Mayo Clinic
FDA OK’s Mayo Clinic’s Automated Stem Cell Producer
Dirk Rodgers speaks at recent FDA public meeting on enhanced drug distribution security.
OPEN-SCS Group addresses DSCSA transaction documentation
Dirk Rodgers speaks at recent FDA public meeting on enhanced drug distribution security.
OPEN-SCS Group Addresses DSCSA Transaction Documentation
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