In response to stakeholder requests, the FDA has delayed the enforcement date only for dispensers under the Drug Supply Chain Security Act (DSCSA) until November 1, 2015.
The FDA is looking for a few (or a lot) more good employees and is holding another virtual hiring event. Could FDA be looking to obligate a portion of the $277 million excess of GDUFA funds that have not yet been spent from the fees collected in the first 2.5 years of the program?
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.
Just a quick note about yesterday’s posted figures, OGD updated the figures as follows:
Approvals 47
In a Federal Register notice today (here), FDA announced its finding that Ondansetron Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.
In a series of FDA Safety Alerts, Recall Notices, and Enforcement Actions over the last couple of years, the Agency has notified consumers of dozens of OTC products that contain undeclared and dangerous drugs.
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 posted its activity associated with the some unregistered wholesalers that target doctors’ offices and clinics offering discount drugs. In addition, FDA has sent letters to doctors and clinics that may have purchased counterfeit or unapproved drugs.
With June 15th quickly approaching, the industry is preparing to discuss the progress under GDUFA I with FDA while also being able to extol the successes and shortcomings of the first iteration of GDUFA.
The month of April 2015 saw the largest number of ANDA approvals since the implementation of GDUFA, with 48 ANDA full approvals and 19 tentative approvals (TAs).
