On Thursday as I was giving a talk to a firm about the abuse-deterrent drug landscape and potential for the future, the firm that makes and markets Opana ER was announcing that it was agreeing to remove its product from the marketplace in accord with the FDA recommendations. During the presentation, I was asked by […]
In just-released figures on the Activities Report of the Generic Drug Program FY 2017, the Office of Generic Drugs (OGD) announced what amounts to a record number of approval actions since the beginning of the GDUFA program and beat the estimated record reported here just a few days ago. This report shows not only the […]
With the caveat that the counts of monthly approvals are not official until OGD publishes those results in an updated version of the Activities Report of the Generic Drug Program, it appears that OGD will break a record of monthly approvals for June 2017. From data gathered from the daily approval report, I find at […]
A few weeks ago, Lachman Consultants participated in the ISPE/FDA/PQRI Quality Manufacturing Conference (“Conference”) in Alexandria, VA. For those that have never attended, this is a particularly dynamic meeting for those that are involved in manufacturing in the regulated industry. There were a myriad of presentations and workshops with members of FDA and industry professionals, […]
FDA Issued a guidance document titled “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy” (here) late last week that described the FDA’s position on enforcement discretion of certain key provisions of the Act that were set to take effect on November 27, 2017 relative to inclusion of product identifiers The […]
Appearing in today’s pre-publication of the Federal Register (here), the FDA announced the issuance of an Emergency Use Authorization (EUA) for an atropine autoinjector that has not been FDA approved to date. An EUA is issued by the FDA once a series of requests have been made and cleared for a product for a potential […]
Revision 3 of Manual of Policies and Procedures (MaPP) 5240.3 was published today and provides an update to include priority review for ANDAs for which there are fewer than three generic competitors. The MaPP also provides boundaries around when an ANDA will be eligible for priority review by providing a more specific set of conditions, […]
The Office of Generic Drugs (OGD) updated its Report of the Generic Drugs Program for May to add some additional figures. While there are no real surprises, it is notable to point out that the number of changes being effected (CBE) supplements soared to almost 700 (690), which is by far the largest number of […]
The Office of Generic Drugs (OGD) has issued a revised Manual of Policies and Procedures (MaPP) updating the new organizational structure and defining where in the CDER and FDA organization reviews of bioequivalence studies with clinical endpoints will be conducted. The MaPP, 5210.4, Rev. 2, makes one thing clear, and that is that the initial […]
While I have never been a big fan of dietary supplements, far be it for me to criticize the entire dietary supplement industry. Clearly there are people that have clinically documented vitamin deficiencies and require supplementation as a result. There are also certain disease states where dietary supplementation is definitively indicated. And, like those of […]
