Information on the FDA’s Monthly Approval Report (here) is usually not complete. Typically, there may be up to a 5-10% discrepancy (lower than actual) in the numbers of Approvals and Tentative Approvals reported. The discrepancy improves over time but seldom do the numbers actually match the reported number of approval actions on the Activities Report […]
Led by Senators Orin Hatch and Edward Markey with sign on by 20 other senators, a letter to Sylvia Burwell, the Secretary of Health and Human Services (HHS), encouraged an increase of the number of patients a single physician can treat in a Medication Assisted Therapy (MAT) program from the current 100 patient limit to […]
Will there be more CRLs to come inspectional and manufacturing deficiencies based on the new integrated review process within the Office of Pharmaceutical Quality? Will FDA truly speak with one quality voice by integrating review and inspection across product review disciplines?
Today, the FDA announced the availability of a draft Guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for Abbreviated New Drug Applications” (here). The document discusses the way in which sponsors should document the adhesion of their proposed product with that the of reference listed drug (RLD). Clearly, for a generic transdermal […]
We have all read about the issue of pay-for-delay, where a generic company gets something in return for a patent settlement and agrees not to market a product for a period of time. The Federal Trade Commission (FTC) is aggressively pursuing such cases as anticompetitive,but that is a topic for another day. Now we may […]
Back in December 2013, I wrote a blog about antibacterial hand soaps (here) that still rings true today after the announcement of a superbug that is resistant to all antibiotics. In that post I wrote: “For years, we have heard scientists voice their concern relative to the widespread use of antimicrobial in the home and […]
Is there a reason to believe that the emergency contraceptive levonorgestrel (LNG), most popularly known as Plan B, may not be as effective in women that weigh more than 165 pounds or have a body mass index > 25kg/m2? According to FDA in a Question and Answers document (here) posted on the Center for Drug […]
There are obviously two schools of thought on the Proposed Rule that would permit generic companies to unilaterally update their labeling to include new safety information. On the consumer advocacy side, and from FDA’s view, it will improve patient safety (but personally I don’t see how). But when you look at the Proposed Rule (as […]
In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.
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). […]
