Regulatory Watch

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

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.

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.

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.

High price tags threaten to block patient access to potentially life-saving cures and treatments.

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.

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

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

CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.

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.

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA puts applications on hold as the agency limits alternative oversight methods.

The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.