Since its appearance in August 2007, the Guidance for Industry, ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients has stood the test of time in providing clear and practical guidance to the pharmaceutical industry, as described in the guidance’s original objective, “provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active […]
We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018. Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA […]
In her new role, Linda will directly support the President and CEO serving as principal interface in key matters and delivering oversight across all Practice Areas, including program management of existing, new, and evolving projects. She will assist in the development of strategic plans and goals, advise on projects and critical issues, and continue to […]
OGD topped the initial projection of both approvals and tentative approvals from my May 2 post (here) hitting 66 full approvals (predicted 62), and 16 tentative approvals (at the time there were only 9) for a total of 82 approval actions. This is good news for the generic industry, as it appears that each month […]
Having attended several conferences where the topic of DSCSA has been discussed, and listening to leading vendors (those that provide both hardware and software) opining on how the industry is behind the eight ball in obtaining equipment and full integration, and validation due to long lead times with the number of vendors available, it appeared […]
On May 3, 2018 at the Food Drug and Law Institute’s Annual Conference, LCS’ President and CEO Fran Zipp participated in a panel with CDER Director Janet Woodcock. Other panelists included Margaret Anderson (Deloitte), Daniel Kracov (Arnold & Porter LLP), and Peter Pitts (Center for Medicine in the Public Interest), moderated by Carla Cartwright (JnJ). […]
The Office of Generic Drugs (OGD) filled in the remaining data boxes in the March Activities Report of the Generic Drugs Program (FY 2018) Monthly Performance (here) and there are some very interesting numbers to point out. Of the 9 refuse-to-receive (RTR) actions OGD issued last month, 6 were for GDUFA II priority applications, 1 […]
The Chart below was posted late yesterday on the CDER webpage. The most notable figures are the mean and median approval times and the significant reductions over those of the first quarter of FY 2018. This appears to indicate that either approval times were much shorter in the second quarter or the number of old […]
By now we all know that the fee structure for NDAs and BLAs has changed with the passage of PDUFA VI. We know that now there are only application fees and “program fees” (program fees are the same as previously assessed product fees). The FDA issued a final guidance entitled “Assessing User Fees Under the […]
The climb back to what we have come to see as the new normal for approvals continued in April. The unofficial April approval numbers obtained through the daily approvals and FDA all approvals databases (here and here) lists 62 full approvals and 9 tentative approvals. This comes after a January low of 25 approvals, February’s […]
