Stephen Hahn mostly coasted through a confirmation hearing to be the next FDA commissioner – but he still didn’t really give any indication of why he wants the job.

US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.

The World Health Organization is to consult on a policy document explaining how it intends to evaluate and list regulatory authorities that meet certain criteria. The new concept of “WHO-listed authority” will replace the current “stringent regulatory authority.”

Brazil’s pharmaceutical industry has welcomed the election of medicines regulator ANVISA to the management committee of the International Council for Harmonization.

A new project by Europe’s Innovative Medicines Initiative that is comparing decentralized and traditional clinical trials was launched just before Janssen announced its own decentralized trial.

Agency is targeting January 2020 for release of controversial proposed rule to allow importation of certain types of prescription drugs from Canada; although most Rx drug-related proposed and final rules on the Fall 2019 regulatory agenda are making repeat appearances, a final rule on electronic distribution of prescribing information has fallen off the list.

A new project by Europe’s Innovative Medicines Initiative that is comparing decentralized and traditional clinical trials was launched just before Janssen announced its own decentralized trial.

Legal experts testify that best option is for all decisions of the Patent Trial and Appeal Board to be reviewed by PTO director; House IP subcommittee wants to restrict ruling that PTAB judges were not constitutionally appointed.

Centers for Medicare and Medicaid Services narrows the types of drugs eligible for add-on payments in the Medicare end-stage renal program as it tries to balance efforts to promote innovation with controlling costs.

US FDA's Office of New Drugs director Peter Stein explained that different review divisions take different approaches in their regulation of biosimilars, but feels their frameworks will become more unified as they gain experience in reviewing biosimilar programs.

The latest news about products accepted into US FDA expedited review programs.

The BioIndustry Association has laid out its wishlist for the next UK administration, including deep regulatory alignment with the EU after Brexit, a more “flexible” approach to health technology assessment appraisals of new drugs, and support for R&D.

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

FDA’s draft guidance on transdermal and topical delivery systems says manufacturers can leverage pharmaceutical development studies principles for device design control requirements.

Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.

FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.