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Mark W. Sherman

Reporter

Washington, DC
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Latest From Mark W. Sherman

Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says

New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.

FDA Leadership

TV Drug Ads: FDA May Pursue Further Research Before Policy Changes

US agency's study found that mentioning fewer risks in direct-to-consumer ads helped with recall and in some cases with recognition but led viewers to say they didn’t have enough information.

Advertising, Marketing & Sales Regulation

Disease Awareness Campaigns Still Must Tread Carefully, Observer Says

Sponsored plotline for General Hospital was careful to avoid irking US FDA; agency withdrew its guidance on disease awareness campaigns in 2015, but its influence appears to be continuing, according to a former official.

Advertising, Marketing & Sales Rare Diseases

Puma May Face Marketing Hurdles Even If Neratinib Wins Final Approval

Neratinib's value as extended adjuvant therapy for HER2-positive breast cancer may be diminished if Roche succeeds in altering the standard of care for initial adjuvant treatment, among other challenges.

Cancer Advisory Committees

Gottlieb Unlikely To Make Major Changes Right Away, Former Official Says

New US FDA commissioners have a lot of housekeeping to do before they can get to the fun stuff, according to former associate commissioner Wayne Pines.

Appointments FDA

FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says

Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.

Drug Approval Standards Neurology
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