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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of wholesaling of compounded drugs in section 503B of the Food, Drug & Cosmetic Act (FDC) are explained in a draft guidance published on June 27. Read More
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 — has prompted the creation of the FDA’s new Oncology Quality, Characterization, and Assessment of Real-world Data (QCARD) Initiative. Read More
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. Read More
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 into the scope, causes and consequences of diseases. Read More
A new FDA draft guidance details what to include in a submission for regulatory approval of patient-matched guides used in pre-surgical planning for 3-D printed orthopedic implant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 knee or hip replacements. Read More
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 be “accurate and understandable” says the FDA in a final guidance issued Tuesday. Read More
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 a report from the EMA released Monday. Read More
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 drugs she is taking clearly are extending her good “on” time so that she has extended periods during the day when she can function with daily activities. I also have seen the difference between good “on” time and “off” time, when the medications start wearing off. Read More
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 Marks. Read More
Citing potential for supply disruptions to patient care, the Healthcare Distribution Alliance (HDA) has recommended a phased approach to the FDA's final implementation of the Drug Supply Chain Security Act (DSCSA) instead of meeting the hard deadline of Nov. 27. Read More
Unauthorized sharing of users’ health data with several third parties — including Google — has gotten fertility app developer Easy Healthcare a $100,000 fine and a federal court order to protect consumer data. Read More
Multiple clinical trial results from two manufacturers posted in the past several days in The Lancet show high levels of success of both weight loss in obese adults and in control of type 2 diabetes through weight loss. Read More