Plan B FOIA lawsuit
This article was originally published in The Tan Sheet
Public interest group Judicial Watch has filed a lawsuit against FDA regarding a Freedom of Information Act request on Barr's Plan B, the group announces March 27. The suit, filed March 21 in the U.S. District Court for the District of Columbia, seeks an order to compel FDA to comply with Judicial Watch's Aug. 22 FOIA request seeking communications between FDA and Sen. Hillary Clinton, D-N.Y., regarding Plan B. FDA approved the drug for OTC use for women 18 and older in August 2006 (1"The Tan Sheet" Aug. 28, 2006, p. 3). "This was a simple request for documents and the FDA's delay in producing them is curious," Judicial Watch says...
You may also be interested in...
FDA's decision to approve emergency contraceptive Plan B for over-the-counter sale to women age 18 and older cracks open the door on a pharmacy-only, behind-the-counter model for nonprescription drug sales
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.