Regulatory

Year characterized by mix of key advances, contentious stances.

Better technology is redefining pharmacovigilance as it expands beyond its traditional compliance focus to become a key business differentiator.

Following closely contested election, approval of FDA bills most likely tabled until new year.

Virtual audits proving to be beneficial post-COVID despite continuing challenges.

Making sense of surprise rejection of draft proposals.

Agency under pressure from both sides—and potential congressional changes could complicate the issue further.

Potential drug removal spotlights latest debate over the expedited pathway.

CBER maps modernization plan to handle surge in research and applications.

Patient safety and data protection concerns highlight hesitancy.

FDA backs joint reviews and common research policies around world.

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.