Regulation

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.

Meeting the regulatory gold standard for drug candidates in ultra-rare diseases can be impractical, a regulatory expert says, but greater collaboration and shared insights from regulatory reviews could help find a viable path forward.

The Philippines medicines regulator explains how it intends to implement the ASEAN mutual recognition agreement under which member states have committed to accept bioequivalence study reports for generics issued by approved BE centers.

The proposed new EU guidance will focus on the regulatory and methodological aspects of clinical trial design and marketing authorization for tRPs, according to a concept paper that has just been issued for public consultation.

The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

Teva resolved two US Department of Justice civil suits accusing the firm of violating the US Anti-Kickback Statute and the False Claims Act by allegedly conspiring to fix the price of three generic drugs and paying Medicare patients’ copays for its multiple sclerosis brand product Copaxone.

Members of the Cardiovascular and Renal Drugs Advisory Committee repeatedly challenged Stealth’s assertion that a new randomized trial in Barth syndrome was not possible, but also said potential functional unblinding and other challenges could compromise a new study.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.