Plan B subpoena stayed
The Justice Department is denying the Center for Reproductive Rights' attempts to subpoena documents from the White House on Barr's OTC-switch application for Plan B. In a Nov. 30 letter, the DoJ says such a subpoena would be "inappropriate" following a stay by a Federal District judge Nov. 21 on a subpoena for FDA documents. The CRR is suing FDA over the Plan B decision-making process (1"The Pink Sheet" Sept. 4, 2006, p. 9)...
You may also be interested in...
Center for Drug Evaluation & Research Director Steven Galson initially signed off on the "not approvable" letter for Barr's emergency contraceptive Plan B OTC switch in fear that he would lose his job, according to testimony by senior CDER officials
Teva CEO Kåre Schultz believes his prediction is coming true for the Truxima biosimilar in-licensed from Celltrion, as he gave the latest update on Teva’s efforts to settle significant legal issues around the US opioid crisis.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.