AbbVie Backtracks on Huge Price Hike for Cancer Drug
Against a backdrop of widespread scrutiny of drug prices, Pharmacyclics opted to scrap a plan to triple the price of its blood cancer drug, Imbruvica (ibrutinib). Source: Drug Industry Daily
West Virginia Says Consumers Can’t Sue Brand-Name Drugmakers for Harm Caused by Generics
West Virginia’s Supreme Court declined to expand the state’s product liability law to cover claims against branded drugs for harm caused by their generics. Source: Drug Industry Daily
340B Program Lacks Price Transparency, Federal Watchdogs Tell HELP Committee
Gauging the 340B drug discount program’s effectiveness requires more price transparency and clearer guidance, expert witnesses told the Senate health committee Tuesday. Source: Drug Industry Daily
TGA Conducts Product Safety Review of Ventilators
Australia’s Therapeutic Goods Administration plans to conduct a product safety review on ventilators used in high-care hospital settings for long-term therapy of intubated patients. Source: The GMP Letter
New Zealand Proposes Fee Hikes for Devices
New Zealand’s Medicines and Medical Devices Safety Authority is proposing fee increases for the majority of its services, including reviewing new devices and GMP inspections. Source: The GMP Letter
FDA Spells Out Policy for Multiple Function Devices
The FDA recommended factors to consider and precautions to take for premarket submissions of multiple function device products, noting there is no all-encompassing approach for the wide variety of multiple…
Japan Raises Medical Device Registration Fees
Japan’s Pharmaceuticals and Medical Devices Agency raised its registration fees for most medical devices effective April 1. Source: The GMP Letter
EU, UK Seek Agreement on Notified Bodies
The European Union and the UK have yet to finalize an agreement in their Brexit negotiations on how to handle notified bodies. Source: The GMP Letter
FDA Releases Guidance on Quality Considerations for Inhalers
The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes. Source: The GMP Letter
FDA Accepts IEC Standards for Ultrasonic Diathermy Devices
The FDA released final guidance that provides policy clarification for ultrasonic diathermy devices as well as information devicemakers should submit in their premarket notification submissions. Source: The GMP Letter
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