Industry News (RSS)

Regulatory Affairs

Eye on FDA RX for Pharma Industry Communications and Planning

  • FDA Adds New AdComm to Address Genetic Metabolic Diseases
    by Mark Senak on March 7, 2024 at 4:05 pm

    Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). As noted in a recent posting here, … Continue reading →

  • What They Said – FDA Press Releases in 2023
    by Mark Senak on February 8, 2024 at 1:27 pm

    Less is more? Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. One might not think that a large agency … Continue reading →

  • FDA’s OPDP Sends First Regulatory Letter of the Year Aimed at Rx Drug Promotion
    by Mark Senak on January 22, 2024 at 7:39 pm

    Last week FDA’s Office of Prescription Drug Promotion issued its first regulatory action letter of the year. This was an Untitled Letter – a/k/a Notice of Violation Letter (NOV) – sent by the agency to Novartis in relation to promotional … Continue reading →

  • The Year in AdComms – A Look Back at 2023
    by Mark Senak on December 7, 2023 at 7:15 am

    For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. Now, with no more … Continue reading →

  • FDA’s OPDP Issues Two New Untitled Letters
    by Mark Senak on November 10, 2023 at 7:01 am

    While enforcement has been at a low ebb for quite some time with FDA’s Office of Prescription Drug Promotion (OPDP), this week took a different turn with the posting of two new untitled letters sent October 31. That brings the … Continue reading →


Biotechnology Industry News | BioSpace RSS Feed for Biotechnology Industry News | BioSpace (Generated by New Sloth)


STAT Pharmalot: Insight and analysis by Ed Silverman Ed Silverman began writing Pharmalot at The Star Ledger of New Jersey in 2007 and it continues to this day at STAT. He joined STAT at its founding in 2015, coming from the Wall Street Journal. He has covered the pharmaceutical industry since 1995. For more insights and analysis, bookmark this page or sign up for his newsletter here.

Human Resources

HR Dive - Latest News Human Resources and Workforce Management News