FDA Issues 46 Fresh Product-Specific Guidances
The 25 New And 21 Revised PSGs Include Guidance On Ophthalmic And Inhaled Products
Executive Summary
The latest batch of product-specific guidance documents to aid generic development has been published by the US FDA, with the 46 new and revised PSGs covering products including an ophthalmic implant, nasal sprays and powders for inhalation.
You may also be interested in...
Shortlist Revealed Ahead Of October Awards
Ahead of the Global Generics & Biosimilars Awards, which are this year being held on Wednesday 25 October at the Hotel Porta Fira in Barcelona, we reveal our final shortlist of entrants across all 14 categories.
Teva Looks To Novartis To Replace Departing Dethlefs
Teva’s commercial interests in North America will soon be under new leadership after the firm announced that Sven Dethlefs would leave the company in mid-November. The firm has looked to the branded sector for his replacement.
Amgen: Regulatory Reform Must Not Tie The FDA’s Hands On Evaluating Biosimilarity
As the US Food and Drug Administration re-evaluates the need for comparative clinical efficacy studies for biosimilars, Leah Christl – executive director for global biosimilars regulatory affairs and R&D policy at Amgen, and former associate director for therapeutic biologics at the FDA – suggests that any reforms should be careful not to tie the agency’s hands in evaluating biosimilarity.