On March 26, 2015, we blogged about an April 20-21 FDA Public Hearing regarding examining the need for the drug enforcement policy surrounding homeopathic drugs. Since the conclusion of that hearing, just under 3500 comments have been received from FDA.
Industry does not always get either the filing type or the need to file the change correct and, sometimes, due to an overabundance of caution, makes supplemental submissions when they may be able to either report the changes in an Annual Report or may not need to report the change at all, but manage it under their Pharmaceutical Quality System (PQS).
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission of NIR analytical methods.
Dr. Kathleen (Cook) Uhl, OGD’s Director of the Office of Generic Drugs (OGD) will be going on an extended medical leave beginning on Monday, March 30, 2015.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.
On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a forum on Data Integrity. The forum will be held in the BALLROOM NAME, the same hotel as the ISPE Quality Metrics Summit, and will be followed by Q&A and a networking and cocktail reception.
FDA issued a Guidance today entitled “Guidance Agenda: New and Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015”.
