Regulatory Beat

FDA has spurred investment to create and develop 600 therapies.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.

Health crises, political tension, and budget concerns were major challenges.

FDA keeps its user fees but fails to gain important reforms.

FDA backs joint reviews, common research policies, and modern production methods around the world.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

FDA will use virtual site visits even after resuming active inspections.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

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

Califf will face challenges that include COVID-19, opioids, and user fees.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.

After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.

A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.