Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]
Introduction On November 17, 2022, Sen. Mike Lee (R-UT) introduced a Bill entitled the “Biosimilar Red Tape Elimination Act” with the intent to increase competition within the US biosimilar market and reduce consumer costs associated their development. The Bill proposes to eliminate the interchangeability requirement of conducting switching studies associated with biosimilar drug development. In […]
The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions. If you have been following the debarment notifications […]
The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]
Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars. With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they […]
An email from the FDA explained that on March 17, 2023 the FDA added information to the Purple Book Database of Licensed Biological Products (here) to include information on new reporting requirements established by the Section 3201 of the Consolidated Appropriations Act of 2023. According to the Purple Book Q&A #8: “Section 506I(c) of the […]
“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (PMC) is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation.” In previous years, the FDA […]
Data integrity (DI) has been a problem for as long as I remember, and my memory goes way back. The first real exposure I had to DI issues dates to the early days of Hatch-Waxman, passage of which had led to the generic drug scandal of the late 1980s. I could write a book about all […]
Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]
As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]
