McCaskill Presses HHS on Efforts to Curb Naloxone’s Rising Cost
In a new attempt to prod action by HHS to lower the price of the opioid-reversing drug naloxone, Sen. Claire McCaskill (D-Mo.) asked HHS Secretary Alex Azar what the department…
Janssen Wins Lawsuit Alleging Risperdal Caused Weight Gain, Diabetes
A Massachusetts court Wednesday ruled in favor of Janssen in a lawsuit that claimed the Johnson and Johnson subsidiary’s antipsychotic Risperdal (risperidone) caused excessive weight gain. Source: Drug Industry Daily
Senate Passes Bill Banning Pharmacy ‘Gag Clauses’
The Senate this week unanimously passed legislation that would forbid insurers and pharmacy benefit managers from imposing “gag clauses” on drug prices. Source: Drug Industry Daily
Health Canada Plans 3D Printing Guidance
Health Canada is developing guidance to help devicemakers seeking to license 3D-printed medical devices. Source: The GMP Letter
FDA Warns Zimmer Biomet for Quality Violations
Zimmer Biomet’s Warsaw, Indiana orthopedic implant manufacturing facility drew a warning from the FDA for quality violations dating back to 2016 after an April inspection revealed ongoing problems. Source: The…
483 Roundup: FDA Flags Seven Firms for GMPs
The FDA hit seven devicemakers for a range of GMP and other violations observed during agency inspections. Source: The GMP Letter
Sponsors Find Benefits, Barriers in Using Real-World Evidence
As the FDA expands its use of real-world evidence, medical device companies are starting to explore the benefits — and the challenges. Source: The GMP Letter
Health Canada Updates Requirements for Class II/III Infusion Pumps
Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new…
TGA Offers New Guidance on Electronic Instructions for Use
Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Source: The GMP Letter
FDA Pushes Back UDI Compliance Date for Combination Products
The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Source: The GMP Letter
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