Regulatory

Biden administration faces key decisions on drug testing and access amid vaccine distribution challenges.

CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.

Applications put on hold as agency limits alternative oversight methods.

Examining the current biosimilar market.

President Trump finally signs the critical year-end COVID-19 package, appropriating $2.3 trillion to finance the federal government through September 2021 and providing critical support for individuals and entities suffering from the economic crisis wrought by the pandemic.

Jill Wechsler reports on FDA's newly published strategies supporting broader eligibility criteria for Phase III studies.

Outlining the steps to a payment approach for Medicare Part D drugs that provides savings for patients.

2020 has proven to be a year like no other for pharma. Here is a quick look back at some of the trends 2020 created for the industry.

Pandemic requires innovative R&D and regulatory flexibility to generate critical vaccines and therapies.

Recent roundtable brought together by Pharm Exec and Parexel features insights from leaders in the pharma industry on the current state and future of RWE.

In unveiling a set of drug price control measures last week, the president displayed his bitterness that vaccine makers failed to announce their success in achieving high efficacy rates for new preventives before the Nov. 3 election.

In a Special Fraud Alert, the Office of the Inspector General of the Department of Health and Human Services advised pharma companies to stop paying high fees to healthcare professionals for giving presentations on certain drugs or treatments. 

Authorities fear distrust of early preventives and complications for ongoing COVID-19 research.

FDA has published a list of critical drugs and medical products for public health emergencies in a bid to reduce reliance on the global pharma supply chain and minimize potential shortages.

Lise Stevens explores what difference the ISO IDMP (Identification of Medicinal Products) data standards would have made in a COVID-19 context — in applications ranging from pharmacovigilance adverse event reporting and electronic prescribing to falsified medicines control.

This week's much-anticipated meeting of FDA’s vaccine advisory committee will address critical issues related to the testing and approval of vaccines to prevent COVID-19 infection.

Missteps threaten agency’s independence as vaccines seek finish line.

Biopharma must find sustainable models for public policy engagement.

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronavirus preventives.

With all eyes on efforts to research and test potential vaccines and therapies to combat the coronavirus pandemic, fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

President Trump has taken on the pharma industry in a surprise move making significant cuts in reimbursement for drugs covered by Medicare.

Tasked with setting up framework for essential medicine program.

Peter Kohut analyses the findings of a survey on how life sciences companies are capitalizing on opportunities to transform workload and data quality management using the latest smart technology.

Industry leaders insist they will maintain high standards for clinical trials and regulatory submissions for new vaccines and therapeutics to combat COVID-19.

FDA to resume “prioritized domestic inspections” for certain regulated products put on hold by COVID-19.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

White House initiative to encourage U.S. production of essential medicines calls on FDA to set program parameters for implement main aspects.

How companies are leveraging Real Word Evidence to evaluate therapies under real world conditions in a broader population at a lower cost than using Randomized Clinical Trials.

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.