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.
Pandemic Brings Major Changes to FDA and Drug Development in 2020
Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.
Trump’s Revenge on Pharma
The Trump administration unveiled a new drug price control policy, drawing opposition from pharma manufacturers and pharmacy benefit managers.
Will COVID-19 Pandemic Finally Establish Drug Quality Metrics?
Drug shortages and supply chain challenges bolster FDA efforts to promote modern manufacturing.
Surge in Cellular and Gene Therapies Challenges FDA
Regulators strive to review flood of advanced treatments while also vetting COVID-19 vaccines.
FDA Caught in Political Crossfire
FDA announced it had issued an emergency use authorization for convalescent plasma that would make it easier to provide this treatment to COVID-19 patients.
Pandemic Spurs Efforts to Boost Pharma Manufacturing in US
FDA can better monitor quality production of domestic versus foreign firms.
Generic Drugs in Spotlight as Pandemic Creates Shortages
FDA and the US Congress support innovation and access to cheaper medicines.
Modern Drug Manufacturing Key to COVID-19 Response
Policy makers seek to ensure supplies of new therapies and to limit shortages.
Biosimilars Poised for Gains in US Market
FDA is encouraging alternative insulins and challenging anticompetitive practices.
Drug Production Draws Multiple Contenders
States, hospitals, and insurers support manufacturing arrangements to ensure access to affordable medicines.
Global Supply Issues Create Challenges
Increased reliance on foreign producers raises concerns and spurs collaborations.
Pharma Regulation to be Shaped by Pricing and Production Issues
Pressures on FDA will affect industry’s success in bringing new therapies to market.
More Consistent Drug Inspection System on Horizon
FDA readies more efficient oversight processes while advancing collaboration with Europe.
Data Integrity Violations Draw Strong FDA Rebukes
Falsified documents and manipulated test results prompt warnings and investigations.
More Predictable Post-Approval Change Policy on Horizon
Industry and regulators seek global system that reduces regional differences.
FDA Maps Strategies to Advance Cell and Gene Therapies
New tools and policies aim to support more complex manufacturing processes.
FDA Revamps Biosimilar Quality Requirements
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
FDA Advances New Approach to Drug Quality Assessment
CDER’s KASA program seeks manufacturer data on drug attributes and risks to inform oversight.
FDA Faces Challenges After Gottlieb
New agency leadership is pressed to promote innovation while addressing safety and quality issues.
Cell and Gene Therapies Gain Streamlined FDA Oversight
FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.
FDA Promotes Quality Standards to Reduce Shortages
Policies emphasize the importance of ensuring data integrity in the United States and abroad.
FDA Sets Records in Approving More New Drugs
Industry investment and regulatory support combined to move many important new medicines to market.
CDER Priorities for 2019: Opioids, Quality, Safety, and Innovation
FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.
FDA Seeks to Revive Quality Metrics Initiative
The agency is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
Biosimilars Raise Manufacturing and Regulatory Challenges
FDA seeks more efficient testing to spur development of less costly biotech therapies.
Manufacturers Under Pressure to Curb Opioid Use and Abuse
FDA and Congress seek to limit the production and distribution of pain medicines.
Gottlieb Tackles Tough Issues in First Year at FDA
FDA’s commissioner addresses opioid abuse, drug costs, and manufacturing quality.
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
FDA Heightens Drive for Transparency
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
Opportunities and Obstacles for Generic Drugs
Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
