September 28th 2023
The agency will be reorganizing field force and compliance functions.
August 1st 2023
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
July 1st 2023
Problems continue despite actions by regulators to better prevent and address drug shortages.
June 1st 2023
An increase in applications for gene therapies is putting stress on FDA’s resources.
May 1st 2023
FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.
Kudos and Hurdles in Tackling Rare Diseases
FDA has spurred investment to create and develop 600 therapies.
Vaccine Development Builds on COVID-19 Breakthroughs
Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.
FDA Interactions with Industry Under Scrutiny
A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.
A Rocky Road Ahead for FDA and Industry
Politics and drug shortages will continue to impact FDA and drug manufacturers in 2023.
Pandemic and Politics Shaped Pharma and FDA in 2022
Health crises, political tension, and budget concerns were major challenges.
FDA User Fees Reauthorized
FDA keeps its user fees but fails to gain important reforms.
Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
FDA backs joint reviews, common research policies, and modern production methods around the world.
FDA In Limbo as User Fee Renewal Stuck on Capitol Hill
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
FDA Joins Effort to Curb Drug Patent Abuses
FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.
Gamesmanship Escalates over FDA User Fee Legislation
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
FDA Advances Quality Initiatives to Combat Drug Shortages
Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.
FDA to Continue Inspection Efficiencies After Pandemic
FDA will use virtual site visits even after resuming active inspections.
FDA and Industry Prepare for Transition from Emergency Use Authorizations
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
FDA Maps Strategies to Advance Pharmaceutical Quality
Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.
A Rocky Road Ahead for Commissioner Califf
Califf will face challenges that include COVID-19, opioids, and user fees.
Global Vaccine Access Challenges FDA and Industry
The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.
Major Challenges Ahead for FDA and Pharma
To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.
Pandemic Alters Policies and Practices for Drug Development and Regulation
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Pandemic Alters FDA Inspections and Quality Oversight
New methods and policies necessitated by the global pandemic are slated to become permanent fixtures in FDA enforcement and regulatory programs.
Can Califf Bring Clarity and Enhanced Credibility to FDA?
After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.
FDA Moves to Advance Innovative Excipients
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.
Biosimilars Move to Center Stage
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
FDA User Fees to Rise and Fall as New Fee Agreements Move Forward
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.
FDA Prioritizes Vaccine Review and Process Improvements
Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
White House Promotes US Drug Manufacturing to Secure Access to Vital Medicines
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
Pandemic Highlights Need for Advanced Pharma Manufacturing
Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
FDA and Industry Move to Renew New Drug User Fee Programs
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
FDA Documents Achievements and Plans for Future
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 Inspection Shutdown Increasingly Delays Approvals
FDA puts applications on hold as the agency limits alternative oversight methods.
Pandemic Control to Shape Biopharma in 2021
The incoming administration faces key decisions on drug testing and access as well as vaccine distribution challenges.
