“It’s All in the Details: Tips for Ensuring a Successful NDA Filing”
A Webinar Presented by The Weinberg Group
Wednesday, November 2, 2011
12 p.m. (EDT) | 9 a.m. (PDT) | 4 p.m. (GMT)
When compiling an NDA for submission, it is common to focus primarily on the content of the technical sections, overlooking important administrative elements until late in the game. This webinar will provide project managers with an overview of these administrative elements and offer tips on coordinating a timely and successful filing. Please join:
Marla Scarola, M.S., Senior Consultant and Lauren Wind, M.P.H, Senior Consultant
Topics will include:
- The value of interactions with FDA
- Required forms and certifications
- Timing of waiver requests
- Preparing clinical files for submission
This complimentary, one-hour webinar is designed to help pharmaceutical project managers understand the elements beyond the nonclinical, clinical and CMC content that are vital for NDA filing and review.
To join the webinar, please register here. Upon receipt of registration, a dial-in number and log-in information will be sent.
As you may know, if your company has used Cetero Research to conduct bioanalytical studies between April 2005 and June 2010 in their Houston facility, your marketing applications may need to be repeated or confirmed. Yesterday, the FDA announced that it was, “asking drug sponsors to identify those tests conducted by Cetero during the designated time frame that were used to support New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). Drug sponsors will need to determine whether any of the testing performed by Cetero should be re-done.”
The FDA has also stated that it, “will send letters to drug sponsors with pending applications, requesting that they either repeat the bioequivalence testing done by Cetero or retest drug samples using a different test laboratory or contractor.” Sponsors of affected NDAs will be asked to re-assay samples, repeat the studies or provide rationale that no further action is needed. Sponsors of affected ANDAs will be asked to repeat the bioequivalence studies or re-assay the samples from the original studies.
The Weinberg Group, a globally recognized regulatory and scientific consulting firm headquartered in Washington D.C., has experience helping pharma companies in these matters. We were, in fact, a key player in remediating the similar MDS Pharma Services crisis at their Montreal facility in 2007, helping our clients prevail with minimal disruption to their organizations and supply chains.
If you are in need of our assistance, please do not hesitate to contact me immediately at 202.833.8077