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Last month we reported OTC Monograph User Fees, Pre-submission Meetings and Electronic Submissions Possible and included our latest paper entitled FDA OTC Monograph Changes Coming: User Fees, Pre-submission Meetings and Electronic Submissions. We noted that although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become…
In January 2017, President Trump issued Executive Order 13771 entitled “Reducing Regulation and Controlling Regulatory Costs” and Executive Order 13777 entitled “Enforcing the Regulatory Reform Agenda.” On September 7, FDA Voice reported “FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework.” Shortly thereafter, FDA began opening…
In July of this year, we reported that FDA Announces Strategic Plan to Eliminate Orphan Designation Request Backlog. On September 12, 2017, Commissioner Gottlieb stated that “Reviews of all orphan drug designation requests older than 120 days were completed on August 28th.” In the same report, entitled “FDA is Advancing the Goals of the Orphan…
The Albert and Mary Lasker Foundation reports that “The 2017 Lasker-DeBakey Clinical Medical Research Award honors two scientists whose technological advances enabled the development of human papillomavirus (HPV) vaccines, which prevent cervical cancer and other tumors. Douglas R. Lowy and John T. Schiller (both from the National Cancer Institute) took a bold but calculated approach toward a major public-health problem whose…
Mostaghim et al (BMJ 2017;358:j3837) recently published a study in the British Medical Journal that concludes that “Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk…