Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
According to Commissioner Gottlieb, “Each year, FDA receives over 1,000 applications for the treatment of patients through expanded access, also known as compassionate use, and the agency authorizes the vast majority (about 99%). FDA recognizes that time is critical for these seriously ill patients who do not have alternative therapies, and who cannot take part in a clinical…
DetailsClinical Informatics News recently reported that “Real-world data sources are combining with traditional data sources—clinical trials, electronic medical records, genomic data, insurance claims, streaming connected devices, social media, meteorological data, and patient reported data—to offer a wealth of possible applications. And now maturing technologies like machine learning and algorithmic methodologies can make sense of these…
DetailsFDA recently announced a new platform to request pre-ANDA meetings. Because PDG spends a considerable amount of time on complex generic development, we enrolled on day one. Here’s a description, followed by a link to the full story from FDA: “On October 1, 2017, the FDA launched a new technology platform, which will allow industry…
DetailsLast 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…
DetailsIn 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…
DetailsIn 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…
DetailsThe 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…
DetailsMostaghim 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…
Details“FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees…
DetailsAlthough not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, OTC User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings with FDA before requesting changes to OTC monographs. The process for effecting such…
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