Filter posts

Opportunities for Patient and Health Advocates

Last week, the seventh annual Patient and Health Advocacy Summit brought  hundreds of patient advocates, …

FDA Protects Patients While Promoting Innovation

Today, 83 percent of children with cancer survive, compared to just 58 percent in the …

ICYMI: WSJ Editors on “Biotech’s Breakthrough Year”

2017 was an amazing year for biomedical advances, with 46 novel drug approvals, a near …

#BIF17: Looking Ahead to 2018 Policy Landscape

The past year has seen a number of important changes in the legislative and policy …

Best Practices for Communication Between FDA and IND Sponsors During Drug Development

The FDA recently released an online course to provide insights to drug sponsors on communicating …

Setting the Stage for PDUFA VI: Recap of Stakeholder Briefing

On July 15, 2016, the U.S. Food and Drug Administration (FDA) released the Prescription Drug …

#BIOCEO16 Session Recap: Regulatory Policy Outlook—PDUFA VI and You

The second day of #BIOCEO16 kicked off this morning with a look ahead to PDUFA …

Biotech Policy Outlook at #BIF15: 21st Century Cures, IPR, TPP, and PDUFA VI

To even the most casual observer, 2015 has been a big year in the biotech …

Forbes: Faster FDA Approvals Have Not Caused More Drug Safety Problems

In 1992, Congress, industry, and the FDA worked together to create the Prescription Drug User Fee …

U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14

During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, …