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Latest From Brenda Sandburg
US Federal Circuit finds in Amgen v. Sandoz that the BPCIA preempts innovator companies from seeking penalties under state law against a biosimilar sponsor that does not engage in the 'patent dance.'
Label restriction, discussions with regulators should keep vaccine in use, Sanofi suggests; Philippines suspended its vaccination program after data showed product can worsen disease in those not previously exposed to infection.
Ban on WAC price increases violates Commerce Clause and reporting requirement violates First Amendment, PhRMA contends; complaint says state officials have not clarified whether law is retroactive.
US agency disagrees that study of consumer and healthcare professional ability to detect deceptive promos is unnecessary; final guidance on product name placement in labeling and advertisements mirrors 2013 draft.
US FDA's annual report on the status of postmarketing requirements and commitments shows 84% of open postmarket requirements for NDAs and 91% for BLAs were progressing on schedule as of Sept. 30, 2016; about half have not yet begun.
US FDA draft guidance suggests efficacy endpoints for testing multiple drug products in the same clinical trials; advances an FDA-EMA joint proposal promoting innovative approaches for development of Gaucher disease medicines.