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 […]
We are pleased to announce that Ricki A. Chase will join Lachman Consultants as a Director in the Compliance Practice, effective June 20, 2016. Ricki Chase comes to Lachman Consultants after an impressive 16-year career, culminating as Director, Investigations Branch at the U.S. Food and Drug Administration where she was responsible for all operations of […]
Just two days after our Tentative Approvals and Receipts post (here), the Office of Generic Drugs (OGD) partially updated its Activities Report of the Generic Drug Program 2016 to include May approval statistics and new ANDA receipts. OGD approved 54 ANDAs and Tentatively Approved 20 ANDAs. (The FDA Monthly approval site still has listed only […]
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?