US FTC sends notices to more than 700 companies about penalties they will face if they use deceptive endorsements and testimonials to promote their products. Industry experts discuss impact of surprising action and cautions to take in teaming up with influencers.

US FTC sends notices to more than 700 companies about penalties they will face if they use deceptive endorsements and testimonials to promote their products. Industry experts discuss impact of surprising action and cautions to take in teaming up with influencers.

Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.

System needs to be changed to enable US FDA to share COVID-19 application data and inspection reports with other regulatory authorities, stakeholders urge. Merck’s Julie Gerberding and former FDA Commissioner Hamburg criticize company announcement of data via press release prior to submission.

Federal government needs to make sure its messaging on vaccines is harmonized, CBER director Marks says. Vaccine development could have been accelerated in pregnant, pediatric and immunocompromised populations, he notes.

In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.