Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain […]
In December 2014, we did a story on First-Time generic approvals for FY 2013 (here). In that post we noted that, for FY 2013, the Office of Generic Drugs (OGD) reported approving 108 first time generic products. This information was taken from OGD’s Generic Approval reports (here) and navigating to 2013’s First-Time list (here). […]
The debate about whether prenatal vitamins are a medical food seems to have been clearly addressed once and for all in a revised Question and Answers Guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition” (here). Among other issues addressed in the Q&A document, FDA clearly states its position that prenatal vitamins are not […]
I have been attempting to compare backlog numbers, receipts of new ANDAs and applications that are in the hands of industry for response to FDA’s Complete Response Letters (CRLs), and it has been quite a struggle. But I think I’ve got it now, and I hope I am right! The way the “backlog” used to […]
We are not entirely sure how FDA makes its decisions to revise a BE Guidance document, but we are clearly in the dark as to how and when the FDA decision to require firms to repeat BE studies using the revised recommendation are made. I am sure that FDA will (as they have with certain products) tell a firm when it is absolutely necessary to repeat a study using a new BE recommendation, but FDA does not do this in all instances. What are the criteria for FDA’s decision making process?
In a Federal Register (FR) Notice published today, FDA indicates that it is seeking comments from the industry and the public on a potential user fee program to support an efficient over-the-counter (OTC) to support the OTC monograph review process. FDA notes that, while overall aspects of the drug, biologics and device review process […]
The Office of Generic Drugs (OGD) received 55 original ANDAs in April 2016, the third highest number of receipts in the 8 months of FY 2016. The two higher months were December 2015 (180) and March 2016 (114). OGD has received a total of 527 ANDA or an average of just a little over […]
As we reported here back in July 2015, FDA has warned patients and healthcare professionals about a potential look-alike, sound-alike naming issue with an antidepressant Brintellix (vortioxetine) and Brilinta (ticagrelor), a blood thinning agent. Yesterday, FDA announced that they had approved a name change for the antidepressant product to Trintellix. This change hopefully will help […]
The Office of Generic Drugs (OGD) fully approved (AP) 53 ANDAs and issued 16 Tentative Approvals (TAs) in the month of April. Thus far in FY 2016, OGD approved a total of 399 ANDAs averaging 57 a month-a 29% increase over FY 2015’s average of 41 a month. Tentative Approvals in FY 2016 total 109 […]
Well, not really-but on April 12, 2016 (my birthday), the FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER) gave a presentation (here) entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” It is quite interesting to note that FDA has been actively involved in the regulatory […]
