Regulatory

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.

Opportunity remains despite regulatory and access obstacles.

Pressurized political, COVID climates greet his return to top spot.

Agency restarts more routine site visits amid slowdown of new COVID infections.

Political issues delay Senate confirmation of Califf.

What marketing authorization holders need to know.

New package to clarify responsibilities for federal health agencies.

Uncertainty over experimental medicines calls for review of AA process.

International collaboration needed to address distribution hurdles.

Scott Swain details the most common roadblocks that pharma companies experience when incorporating real-world data (RWD) in regulatory submissions and looks at how they can be addressed.

In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.

Progress in 2022 will require nimble action across several fronts.

As the pressure on teams reviewing promotional content has increases, both in terms of volumes of content and complexity, Sameer Lal discusses the need for a near-term strategies using artificial intelligence (AI) and machine learning (ML) to decongest bottlenecks of the manual review process.

Despite major challenges and demands created by the coronovirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market.