FDA Releases Slew of Product-Specific Draft Guidances
The FDA published new product-specific draft guidances for establishing bioequivalence in 20 drugs and combinations. The agency also revised draft guidances for 12 more substances. Source: Drug Industry Daily
Advisory Committee Unanimously Recommends Avastin, Herceptin Biosimilars
An FDA advisory panel unanimously recommended that the agency approve two biosimilars for the cancer treatments Avastin (bevacizumab) and Herceptin (trastuzumab). Source: Drug Industry Daily
Congress Probing Changes to Off-Label Use Rules
Congress is looking into making statutory changes to the way FDA governs off-label use of medical products and other pre- and postmarket communications between medical manufacturers, physicians and patients. Source:…
TGA Plans to Auto-Approve Low-Risk Product Variations
The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes…
NICE Recommends Kadcyla, Kyprolis and Rejects Besponsa Coverage
The U.K. is planning to move Roche’s Kadcyla (trastuzumab emtansine) into the NHS’s routine funding programs later this summer, following guidance from the National Institute for Health and Care Excellence…
FDA Updates Part 11 Guidance to Include Mobile Tech, Wearables
The FDA has released a new draft guidance that clarifies the Part 11 regulations for electronic records and signatures as they apply to clinical trials, including validation of mobile and…
EMA Unveils Action Plan to Support Small- and Mediuma-Sized Companies
The European Medicines Agency announced a three-year, 16-point action plan to boost small- and medium-sized pharmaceutical companies. Source: International Pharmaceutical Regulatory Monitor
Indian Drugmaker Receives Import Ban After Drug Shortage Ends
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be…
EC Publishes New Action Plan for Antimicrobial Resistance
The European Commission updated its 2011 action plan against antimicrobial resistance, pledging to boost research into the development of new treatments and alternatives — including support for small- and medium-sized…
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