Pink Sheet

For Coronavirus US FDA Is At The Podium But Not On The Task Force

By Derrick Gingery 27 Nov 2020

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

Topic FDA Vaccines Infectious Diseases Coronavirus

Pink Sheet

Webinar: FDA and its Commissioners

By Nielsen Hobbs 27 Nov 2020

The US FDA has experienced an extended period with an acting commissioner. However, the agency continues to achieve its user fee dates, and hardly appears rudderless. Still, having a confirmed commissioner will give FDA more stability and power. But with application review looking to become more efficient and flexible, what could a new commissioner do to change the relationship between industry and FDA?

Topic FDA

Pink Sheet

What Did US FDA Do Wrong In Its Review Of Aducanumab AdCom Members Have A List

By Brenda Sandburg 17 Nov 2020

Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.

Topic advisory committees Drug Review FDA

Pink Sheet

What Justice Ginsburg's Death Means For Pharma

By Nielsen Hobbs 22 Sep 2020

A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.

Topic US Election 2020 FDA

Biomedtracker

The Race to Find a COVID-19 Treatment - Infographic

29 Apr 2020

Access this infographic which focuses on Gilead’s drug Remdesivir which currently shows the greatest promise for the likelihood of approval as a possible treatment to effectively treat the virus. The infographic highlights the drug summary and profile, the number of patients in each trial phase, and the history of events that have moved this product through the development process.

Topic Coronavirus FDA Drug Review

HBW Insight

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

By Malcolm Spicer 27 Jan 2020

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

Topic Drug Review FDA OTC Drugs

HBW Insight

Future of CBD In Supplements: NDI Notification Looms As Regulatory Path

By Malcolm Spicer 06 Dec 2019

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

Topic Dietary Supplements FDA

Pink Sheet

Former FDA Commissioner Frank Young Passes Away At 88

By Michael Cipriano 28 Nov 2019

From the approval of AZT to the generic drug scandal, Frank Young oversaw many seminal events at US FDA while commissioner from 1984 to 1989. After leaving the agency, he managed the approval of the NDA for Braeburn's opioid dependence drug Probuphine. Young passed away following a short bout with cancer.

Topic FDA Leadership Regulation

HBW Insight

Sunscreen Industry Faces Major Challenge In GRASE Push That OTC Monograph Reform Would Solve

By Ryan Nelson 28 Nov 2019

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

Topic FDA Regulation