As a group of consultants to domestic and international pharmaceutical companies, we work with many clients responding to inspectional findings from an FDA inspection. At the close of the inspection, an FDA-483, Inspectional Observations form, may be issued to the firm’s management outlining conditions, which the FDA investigator(s) believe may constitute deviations from applicable law […]
The FDA today released a technical reference document entitled, “Quality Metrics Technical Conformance Guide for the Implementation of the Draft FDA Guidance for Industry on Requests for Quality Metrics.” This Guide supplements the above referenced draft Guidance and outlines how the FDA would like the information on quality metrics collected and reported. Remember that, as stated […]
With much activity still surrounding compounding pharmacies and outsourcing facilities, and with enforcement action still on the rise, today FDA issued two final Guidance documents that describe the types of bulk drug substances that can be used for compounding for section 503A (pharmacies) and 503B (outsourcing facilities) without FDA enforcement action. This also obviously assumes […]
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?
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 […]
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 […]
In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity.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.
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 […]
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 […]
