The new draft guidance entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 — Questions and Answers, “clarifies, updates and expands upon” a draft guidance issued in 2003 and “provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and…
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As pharmaceutical consultants engaged in the compilation and submission of marketing applications, we are frequently called upon by our clients to address all or part of their BPCA and PREA needs. This paper is meant to serve as a review and primer for anyone at the Pre-IND stage or who is confronted with the need…
DetailsRecent events have occurred within FDA that promise to bring previously unavailable therapeutically equivalent generic drug formulations to the U.S. market. Patients, prescribers, pharmacists and generic manufacturers all stand to gain from these initiatives: On June 21, new FDA Commissioner Scott Gottlieb announced (in FDA Voice) that “Too many patients are being priced out of…
Details“Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic…
DetailsAccording to a SCOTUSblog Opinion analysis on June 12, “The Supreme Court reverses another Federal Circuit patent case… Sandoz emerged as the clear victor in the case, winning the right to bring “biosimilar” versions of complex biologic drugs to market sooner and also gaining a small but potentially important procedural right for future litigations.” FiercePharma…
DetailsJune 9 – FiercePharma reports “AMA aims at DTC ads again, this time to push inclusion of drug prices…Physicians attending the AMA annual conference in Chicago this weekend will again turn their attention to DTC ads with a new proposal to push drugmakers to list retail pricing, much like automakers do…Resolution 236 was introduced by New England medical societies from Connecticut,…
Details“The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration’s (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House. The committee also adopted several amendments to the version of the bill, known as the FDA…
DetailsFDA June 5 – FDA launched a mobile application (app) to offer access to National Drug Code (NDC) data from phones or tablets. The new app, NDC Express, presents the NDC database in a mobile-friendly format, using display and navigation features available in both Android and iOS devices. The Drug Listing Act of 1972 requires…
DetailsJune 1 – ScienceDaily Publishes “Why antibiotics fail” When a patient is prescribed the wrong antibiotic to treat a bacterial infection, it’s not necessarily the physician who is at fault. The current antibiotic assay — standardized in 1961 by the World Health Organization and used worldwide — is potentially flawed.” Here’s the full story (University of…
DetailsPDG extends its sincere thanks to DIA, Freeman, Spargo and fellow participants for making the Chicago DIA 2017 Annual Meeting a great one. We would also like to congratulate our fitbit winner, a Regulatory Affairs Director at a Central NJ pharmaceutical firm. Click here to visit DIA or here to contact PDG.