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:
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Hydrochloride Injection USP, in plastic, ready-to-use containers containing 32mg/50mL was removed from the market and withdrawn for safety reasons.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).
The FDA has published a Federal Register Notice announcing the reopening of the administrative record on the Tentative Final Monograph (TFM) for Topical Antimicrobial Drug Products for Over-the-Counter Human Use.
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
In the Federal Register today, FDA announced a public meeting to be held on June 15, 2015 at the FDA’s White Oak campus. The purpose of the meeting is to get the public’s input on the potential reauthorization of the Generic Drug User Fee Act (GDUFA).
The FDA is warning about some counterfeit Botox that has been found in the United States. The product looks similar to the brand name product but “[B]oth the outer carton and vial on the suspect product are counterfeit.
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.
In a Federal Register Notice scheduled to publish on Monday April 6th, FDA outlines a proposal to study the comparative advertising of prescription drug products.
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.