Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
Draft guidance pulls from Ophthalmic Devices Panel and Risk Communication Advisory Committee 2017 meeting to discuss more clearly communicating risks of the solutions to consumers while allowing products to remain available OTC.
Members led by SC Republican Jeff Duncan and CA Democrat Tony Cárdenas, in letter to House speaker and minority leader, oppose MPL provision in latest version of S.4348 for re-authorizing FDA drug, biologic and medical device user fee programs.
In recent interview, CEO Blake Cadwell talked about Soundly’s business model and outlook for hearing aid marketplace after FDA's pending publication of rule aiming to make the devices more accessible. Firm since June has offered online testing and advice for customers about hearing aids best suited for their needs.
Establishing VMS products MPL as stated within legislation to re-authorize FDA user fee programs for drugs, biologics and medical device applications isn’t urgent enough to prevent passing user fee bill, says CRN chief Steve Mister.
Under Senate legislation proposing mandatory listing with FDA for all supplements sold in US, a product labeled in compliance with all other agency regulations would be deemed misbranded if not registered for proposed list.
As it did when it halted sales in US and Canada in 2020, J&J’s latest announcement attributes its decision as coming from a “portfolio assessment” and stated it remains confident in using talc in baby powder and cosmetics.