Pharmaceutical Development Group (PDG) is a subsidiary of Biotech Research Group Corporation.
In remarks made to the FTC on November 8, 2017, FDA Commissioner Scott Gottlieb, M.D. stated, in part: “So my message is this: end the shenanigans. Branded companies’ use of REMS – which FDA adopts as a way to ensure the safe use of certain drugs – is also sometimes being used as a way…
In October of this year, FDA issued guidance that for the first time formalized the Pre-ANDA Meeting for developers of complex generics. Entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products,” “This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has…
US News & World Report recently reported “Massachusetts Grabs Spotlight By Proposing New Twist On Medicaid Drug Coverage Other states are watching closely, officials say.” Following is an excerpt: “In the absence of new federal policies to tame break-the-bank drug prices, Massachusetts’ state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the…
On November 22, 2017, EMA launches a “new and improved” version of EudraVigilance (analogous to FDA Medwatch program). The result will be a total transition in the way that Individual case safety reports (ICSRs) are tracked and reported throughout Europe. ICSRs will be reported to the EudraVigilance database in the E2B(R3) format, replacing the E2B(R2) format.…
The AAPS 2017 Annual Meeting & Exposition will be held in San Diego November 12-15. The exhibit hall will be open as follows: Monday November 13, 2017 10:30 AM – 5:00 PM Tuesday November 14, 2017 8:30 AM – 5:00 PM Wednesday November 15, 2017 8:30 AM – 1:30 PM CROs: come see us about…
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…
Clinical 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…
FDA 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…
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…