FDA investigator financial disclosure rules should cover company officials only -- Medtronic.
This article was originally published in The Gray Sheet
CLINICAL INVESTIGATOR FINANCIAL DISCLOSURE: MEDTRONIC PROPOSAL suggests requiring financial disclosure to FDA only "when a physician is a principal owner of a company, is an officer of a company, or on the board of directors of a company whose products are being investigated." The Medtronic proposal was made in recent supplementary comments on FDA's Sept. 22, 1994 proposed rule on financial disclosure by clinical investigators.
You may also be interested in...
Lannett will launch a further seven products in fiscal 2021, after launching four products recently in the first quarter of FY21. The company also plans to pay off its Term Loan ‘A’ in full, by the end of November 2020.
Pfizer has now received a formal European Commission approval for its Nyvepria biosimilar pegfilgrastim. The approval puts the firm in direct competition with several other versions of the Neulasta original.
AstraZeneca's research head admits that the half dose approach was a lucky mistake - but one that could boost the vaccine's effectiveness and supplies. The US regulator may not be persuaded, however.