Regulatory

With heightened government scrutiny on educational forums, biopharma manufacturers need a sound framework that demonstrates they are following best practices.

A proactive and tailored compliance department—with the nimbleness to adapt strategies on the fly—is a critical shield for life sciences companies during government investigations.

Legislative-reform alliance makes for strange bedfellows.

Amid push to include this population more in clinical trials, the goal is to uncover improved evidence on the risks/benefits of drugs for these patients.

Takes aim at actions that limit access to lower-cost drugs, calls for revamp of M&A-impact guidelines.

Agency leaders seek to build public trust in science and gain support for regulation.

Measure tackles infant formula, cosmetics, and diagnostics—plus drug development and access.

Agency again pursuing manufacturer rating system.

Oncology drug developers must start asking questions in preparation of FDA’s dose optimization initiative.

Drugmakers join the chorus of blaming pharmacy benefit managers for high product costs, limited access.

Though exclusions exist, agency’s new guidance backs the belief that US can reduce costs by importing cheaper, but legitimate products from Canada or elsewhere.

Its use enables key processes such as early access, regulatory approval, and reimbursement listing.

Recent explosion at Zaporizhzhia nuclear power plant in Ukraine shows how pharma industry can pull together and take action in the face of adversity.

Plan to keep new methods adopted during COVID in place.

Access to mifepristone, approved by the agency in 2000, also under microscope.

Medical device user-fees agreement, Aduhelm approval and access among issues in crosshairs.

As regulatory reform continues to evolve in the US and Europe, the role of regulatory affairs is poised to help shape the more personalized treatment landscape on the horizon.

Dual efforts focused on more inclusive research and more diverse enrollment in pre- and post-approval studies.

Transition likely with looming end to emergency use authorizations tied to COVID-19 pandemic.

Program looks to establish framework for agency and purchasers to “objectively rate” manufacturing sites.

Congressional bills put focus on comparator-drug access, more accurate trial and R&D cost determinations.

Fresh round of discussions around health technology assessment.

Several legislative initiatives on table that would extend agency’s reach.

IP claims under microscope amid arguments over R&D policy and investment.

Measures being mulled to reform the AA process and address public concerns around its risk-benefit payoff.

Quality metrics, more domestic production aim to avoid supply disruptions and drug shortages.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Pharma and legal experts weigh in on the rush to secure intellectual property around psychedelic medicines, the value imperative that should govern pricing strategies, and the likely long-haul battle for more widespread decriminalization of these drugs.

Agency clarifies stance on applications for ‘me-too’ drugs not supported by multiregional trials.