Top Ten Regulatory News Stories – Week Ending August 18, 2017

The new FDA commissioner Scott Gottlieb said brand name drug companies are “gaming the system” to block generic competition and vowed to do something about it.  https://www.usatoday.com/story/news/politics/2017/08/15/fda-chief-says-drug-makers-gaming-system-slow-generic-competition-vows-action/568698001/ The EMA Committee for Human Medicinal Products (CHMP) adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). http://raps.org/Regulatory-Focus/News/2017/08/14/28239/EMA’s-CHMP-Adopts-Updated-Guideline-on-Manufacture-of-Finished-Dosage-Form Pfizer[…]

Regulatory Roundup: Top News Stories – Week Ending August 11, 2017

There have not been any new drug approvals so far this week but the FDA granted a few new Orphan Drug Designations and Priority Reviews. Here is my summary of the top regulatory news stories this week for pharma and biotech: The FDA is on track for most generic drug approvals ever for Fiscal Year[…]

Regulatory Roundup: Top News Stories – Week Ending August 4, 2017

There was a lot of regulatory news this week including an extension of the PDUFA bill, FDA approval of two New Molecular Entities, and an approval of the first treatment for Chronic Graft Versus Host Disease. Here is my summary of the top regulatory stories this week: The US Senate passed a bipartisan bill to[…]

Regulatory Roundup: Top News Stories – Week Ending July 28, 2017

There were several guidance updates from the FDA this week along with several new medicine approvals by the EMA. And the anticipated FDA layoffs have been delayed for now.  Here is my summary of the top regulatory stories this week: 1.  FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after September[…]

Working with an Executive Recruiter

I talk with many job seekers who have never worked with an executive recruiter in the past, or they are not sure how they should work with recruiting firms.  So I am writing a blog this week about the recruiting process, what candidates should expect, and how job seekers can work most effectively with recruiters.[…]

Regulatory Roundup: Top News Stories – Week Ending July 21, 2017

This was a relatively quiet regulatory news week when compared to the past few weeks.  Here is my summary of the top stories to follow: The FDA approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer. https://www.firstwordpharma.com/node/1488664 The FDA approved Gilead’s VOSEVI, a three-drug combination of[…]