We are pleased to announce that Constance Richard-Math has accepted the position of Director in the Compliance Practice at Lachman Consultants. Constance Richard-Math joined Lachman Consultants after a 20-year career at the U.S. Food and Drug Administration where she rose to the position of Director, Investigations Branch at the Baltimore, Maryland District Office. While at […]
The Office of Generic Drugs (OGD) posted its updated Dashboard for ANDA workload activity on Friday. The new posting is current through the first quarter of FY 2018 as of January 1, 2018. Original ANDA Activity for Pre-GDUFA Year 3 Application Cohort Total Original ANDA Workload Activity for All Unapproved Applications Clearly, FDA is resolving […]
As noted in a previous blog post (here), I did not expect ANDA approvals to reach anywhere near normal levels for a few months. Since that post, OGD has posted a few more approval actions; the official numbers for February were reported today at 32 full approvals and 5 tentative approvals (as opposed to 29 […]
Even with this season’s flu season past its peak, FDA is warning consumers about potential fraudulent product touted as curing or lessening the flu. The FDA health fraud alert (here) warns consumers to be aware of fraudulent product claiming to treat, prevent, or lessen flu symptoms. In addition, they also warn patients to be wary […]
The US FDA just released their Guidance for Industry titled “E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)” (here). The guidance provides a path forward for the mutual acceptance of clinical trial data across regulatory authorities from Canada, the European Union, Japan, Switzerland, and the United States. The guidance clearly identifies the added revisions, […]
According to the FDA all Approvals list (here), approvals for February 2018 did inch up a bit to 29 full approvals and 4 tentative approvals, but they are still far below the OGD norm. We had previously predicted that it would take about 3 months before the approval train got back on track, and now […]
The FDA has issued a guidance (here) that provides clarification on the definitions of suspect and illegitimate products under the Drug Supply Chain Security Act (DSCSA). The definitions are designed to help those in the supply chain better and more accurately characterize problem products they may uncover. The guidance provides the following definitions: SUSPECT PRODUCT—The […]
