Regulatory

The ‘skinny’ user fee reauthorization tables multiple high-profile proposals.

Agency releases a series of new guidances to advance the reliability of patient-focused tools and methods.

Seek pared-down measure in funding bill to avert shutdown.

Agency officials express associated concerns around clinical trial data reliability and quality.

Administration launches national manufacturing initiative, with aim to reduce US reliance on biomedicine from China and other regions.

In countdown to renewal deadline, agency already feeling the effects of still-unclear legislative fate.

FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.

Pharma loses battle to block price negotiations, but implementation faces many challenges.

Proposed SoHO reform elicits wide support, but risks acknowledged.

Democrats approve curbs for Medicare plans, but not for commercial drug coverage.

Better clinical data needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.

Citing strong reporting results, hybrid model to continue supplementing on-site inspections.

With debate swirling around products cleared through this pathway, reforms and tighter oversight likely.

With the renewal deadline looming—and disagreement still swirling on enhancing FDA authority—a counter proposal calls for a streamlined, fee-only bill.

Application for OTC contraceptive highlights efforts to broaden access to medicines.

Agency partners with patent office in addressing anticompetitive practices.

Some states look to block access to approved drugs.

Issue represents a potential threat in fighting future pandemics.

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.