Biopharma sponsors should start with information that needs to be disclosed to satisfy SEC rules and understand how a press release will be used to avoid running afoul of agency regulations, industry exec says; company contracts with investigators also should set limits on what they can say about an unapproved drug.
Corporate press releases announcing information that is material to investors, and clinical investigator comments about pipeline drugs, can create pre-approval promotion enforcement risks for biopharma companies, regulatory and legal experts say.
When it comes to corporate communications, companies should begin with information that needs to be disclosed to satisfy Securities and...
The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.
