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 Best Pharmaceutical for Children Act (BPCA) and Pediatric Research Equity Act (PREA) needs. This paper is meant to serve as a review and primer for anyone at Pre-IND…
DetailsPDG recently reported that FDA took the unprecedented step of publishing a list of off-patent, and off-exclusivity branded drugs without approved generics. The agency intends to update this list every six months. At the same time, the agency implemented a new policy designed to “expedite the review of generic drug applications where competition is limited.”…
DetailsReceived from CDRH July 10, 2017: “Today’s Federal Register announces a list of 1,003 class II device types that the FDA believes are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. In an effort to decrease regulatory burdens on the medical…
DetailsFiercePharma reported on July 7, 2017 that “After backing candidate Donald Trump last year, antivaccine activists may feel betrayed in his administration’s latest move to name vaccine advocate Brenda Fitzgerald to run the CDC. At the same time, the medical community will likely breathe a sigh of relief on the nomination. Health and Human Services…
DetailsFDAnews Drug Daily Bulletin reports that “FDA is proposing to shorten ANDA review timelines for certain generics sponsors that submit advance information to the agency. PFCs are one of several enhancements specified by the GDUFA II commitment letter to streamline the review process for priority ANDAs. In the commitment letter, the FDA pledged to review…
DetailsThe new draft guidance entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 — Questions and Answers, “clarifies, updates and expands upon” a draft guidance issued in 2003 and “provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records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…
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