HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.
Recruiting has started for a 900-subject study that could be a key to submitting a new drug application to US FDA for making a daily oral contraceptive available OTC.
HRA Pharma SA started recruiting in April for an actual use trial, using progestin-only oral contraceptives with norgestrel 0.075 mg, and expects to complete the study in April 2019,...
CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.
The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.
Pink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters.
With European biosimilars developers buoyed by recent regulatory moves, Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil discuss the next steps forward for the industry.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
