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 […]
Congress has introduced the Compounded Drug Access Bill, H.R. 2871. This blog article only addresses the first four sections of H.R. 2871, “Preserving Patient Access to Compounded Medications Act of 2017”. Here we go again with another introduced bill for pharmacy compounding. This six-page bills title (above) purports to “preserve” patients’ access to compounded drugs […]
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 […]
