US FDA’s Confidentiality Policies Seen As Big EUA Shortcoming
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.
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US Real-World Evidence On COVID-19 Vaccine Safety Is Inadequate, Former HHS Official Says
US government does not have an adequate system to monitor vaccine safety in real time, Nicole Lurie, former assistant secretary for emergency preparedness says. Low-income countries sometimes do not receive same COVID product that FDA reviewed, a former agency official notes.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
Biopharma Industry Sharply Divided Over Supreme Court Antibody Patent Brawl
Big biologic makers line up on opposite sides of dispute between Amgen and Sanofi over whether Amgen’s Repatha patents cover analogous antibodies with the same functional characteristics.