Is April the Turn Around Month for Generic Approvals?
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).
Proposed Amendment to Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human Use
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.
Additions to Guidance Agenda for 2015
The FDA has published a revised listing of its new Guidance agenda for 2015 with a number of additions.
And so It Begins! GDUFA Act II
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).
Here’s a New Wrinkle – Counterfeit Botox Found in the US –Again!
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.
A New FDA Draft Guidance Document for Near Infrared (NIR) Spectroscopy
The FDA has released a Draft Guidance entitled, “Development and Submission of Near Infrared Analytical Procedures – Guidance for Industry,” which covers the development, validation, and submission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.
Comparative Prescription Pricing – Office of Prescription Drug Promotion (OPDP) to Take a Look
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.
News Flash – OGD Leader to Go on Medical Leave
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.
Homeopathic Drugs Enforcement Policy to Undergo Review?
FDA is scheduling a Public Hearing on April 20 and 21, 2015 to obtain comments from stakeholders on the application of the enforcement policy related to homeopathic remedies. FDA indicated that they have not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over 25 years.
Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”
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.
