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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 …

GMO Labeling Next Steps: "USDA is Preparing for the Onslaught."

Last week, the U.S. House of Representatives voted 306 to 117 to pass legislation that …

FDA Commissioner Califf to Industry at #BIO2016: Talk to Patients

Industry should work with patients and their advocates to better understand their experiences, what they’re …

Orphan Drug Tax Credit is Crucial to Rare Disease R&D

The term “rare disease” may be misleading: to be “rare” a disease must effect fewer …

2015 FDA Approvals: Highest Levels in Over a Decade

2015 was a blockbuster year for FDA approvals of novel new medicines, many of them …

The March of Genetic Food Progress

You may already be familiar with Julie Kelly’s contributions to the Genetic Literacy Project but you may …

“Please Wait a Few Moments While Your Pill Prints”

Since the late 1980’s, innovators have dreamed of living in a world where science could …

Congress, Media Focused on Biotech Food Labeling

Media coverage of the biotech food labeling debate is at a fever pitch as the …

FDA Acts on Biosimilars

The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration …

Expanding the Role of Patients in Drug Development

Working alongside scientists, universities, and biotech companies, patients and patient organizations have the ability to …