The European Academy of Paediatrics (EAP) and 22 other European medical associations have written to the European Commission (EC) to warn that critical pediatric medical devices are being squeezed out…

The FDA’s interpretation and policies on exemption as well as prohibition of wholesaling of compounded drugs in section 503B of the Food, Drug & Cosmetic Act (FDC) are explained in…

Receiving oncology study submissions that propose a too-wide range of types and formats of real world data (RWD) — along with a lack of basic elements of study design —…

Upcoming events in the coming weeks include three FDA advisory committee meetings as well as webinars on the FDA's sterilization pilot and design control. Source: Drug Industry Daily

WHO and the International Council for Harmonisation (ICH) plan to establish a unified language that streamlines global regulatory decision making on the safety and efficacy of drugs, while offering insights…

A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant systems such as…

When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should…

There’s a need to tap into a greater array of data sources, identify and consider research questions earlier on, and speed up the generation of real-world evidence (RWE), according to…

I am good friends with a woman with Parkinson’s disease. When I see her, I feel grateful that this is the most exciting time in history for medical advancements. The…

The FDA’s June 22 Accelerated Approval of Sarepta’s gene therapy Elevidys for Duchenne muscular dystrophy (DMD) is appropriate, despite an apparent disagreement within the department, according to CBER Director Peter…