Opill AdCom Delay Not Unusual – Will Evaluation Of US OTC Switch Proposal Continue In The Norm?
Whether FDA handling of HRA Pharma’s OTC switch NDA for 0.075-mg norgestrel continues along normal arc is question which prompts concerns. “I hope that they don't make the same mistakes that were made back on the Plan B,” says Susan Wood, an associate professor at George Washington University School of Public Health and a former FDA office director.
You may also be interested in...
Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.
FDA decision on Perrigo subsidiary’s proposal for first US OTC daily oral contraceptive is extended 90 days with the postponement of an advisory panel meeting. Agency requested additional information related to OTC switch application of 0.075-mg norgestrel initially submitted in July.
Experts spoke with HBW Insight about potential impact on US contraceptive market from Supreme Court’s decision in Dobbs v. Jackson overturning its 1973 ruling in Roe v. Wade, which was upheld in 1992 ruling in Planned Parenthood v. Casey, stating a woman has a constitutional right to reproductive health services.