The latest drug development news and highlights from our US FDA Performance Tracker.

INTERACT program will allow sponsors to ask FDA questions about manufacturing and other technical issues to help streamline development.

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Firms want Fifth Circuit to review whether federal law preempts failure-to-warn and design-defect claims; ruling in their favor could end 20,000-plus pending US cases.

Magistrate judge says Boehringer's theory 'may or may not be viable' as an infringement defense; permits third party subpoenas for information on clinical trials.

Promising non-traditional antibiotic therapies need a clear path to market to entice investment, US Biomedical Advanced Research and Development Authority official says.

With Flatiron, Roche is at the forefront of the emerging field of RWE. Roche Pharma President O’Day described how the company is using such data in the real world of regulation and reimbursement.

The four latest products to be accepted onto the European Medicines Agency’s popular priority medicines scheme target mantle cell lymphoma, chikungunya, hematopoietic stem cell transplant patients, and the rare monogenic disease, X-linked myotubular myopathy.

Third-party value assessment organization says AbbVie/Neurocrine's elagolix would be cost effective for endometriosis and associated pain, using a placeholder price of $7,000 per year. But the cost would be substantial for health budgets given the broad prevalence of the condition. 

Bills allowing pharmacies to substitute biosimilars for reference biologics have been enacted in all but six states. Interactive map notes state-by-state provisions.

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

US FDA touts new evidence that high performance of pharmaceutical manufacturing sites on 10 quality maturity metrics correlates with robust pharmaceutical quality systems, operational excellence and good business. An FDA-funded study by St. Gallen also finds that low performance, on the other hand, correlates with manufacturing problems.

Generic industry officials ask that information requests and discipline review letters be issued during ANDA amendment assessments, but the US agency says they are not allowed in GDUFA II.

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.

"We can say we are OTC but the botanicals are doing a lot of the heavy lifting," says Kelli Rodriquez, the firm's sales and marketing chief. Salicylic acid supports the acne treatment claim under an OTC monograph; leaving out benzoyl peroxide, an allergen for some consumers, also allows labeled use more frequently with a claim of faster symptom reduction.