As you are well aware, the negotiations for GDUFA II have culminated in the release of the new GDUFA II Goal Letter and has improved (at least on paper) the chances for additional improvement in the speed of generic drug approvals. The initial overall baseline price tag for GDUFA II (starting on October 1, 2017) […]
The theme of Wednesday October 26, 2016 at the GPhA Fall Technical Conference was Patent and Exclusivity day (at least for part of the day) and in the category of “you learn something new every day!”, it was Pediatric Exclusivity that took the stage for me. Turns out that, if you are an ANDA applicant […]
Over the years I have been trying to convince firms that certain changes to approved ANDAs must always be filed as a Prior Approval Supplement (PAS) or, in some cases, these changes may be handled as a Comparability Protocol that is approved in an ANDA. At the GPhA Fall Technical Conference yesterday, Dr. Lucinda (Cindy) […]
The Office of Pharmaceutical Quality (OPQ) was launched in early 2015 with a slogan of “One Quality Voice”. With Michael Kopcha, Ph.D., R.Ph. as the Director of the Office of Pharmaceutical Quality at CDER, and with approximately 1000 personnel in his group, OPQ’s objectives are as follows: a) streamline the regulatory processes and integrate major […]
There is no doubt that the Office of Generic Drugs (OGD) is receiving more work than it anticipated under the negotiated GDUFA I program. Dr. Kathleen (Cook) Uhl, Director OGD, noted that OGD received over 5 years of work in the first 4 years of GDUFA I, noting that the Agency anticipated receiving only about […]
This blog post was coauthored by Kurt Karst, Director, Hyman, Phelps and McNamara If there’s something strange in your neighborhood; Who you gonna call? If there’s something weird, and it don’t look good; Who you gonna call? Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange or weird compliance-wise going on […]
We asked around about what issues were driving firms crazy and these same three issues surfaced most often: 1) getting resolution of compliance status after inspection or re-inspection; 2) getting a straight answer from the Agency; and 3) what to do about maximum daily exposure issues relative to the Inactive Ingredient Database (IID). Taking each […]
Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets. The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in […]
Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection. However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to […]
Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”. Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells. While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted […]
