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Latest Blogs

New and Revised Product-Specific Bioequivalence Guidances Announced

In the prepublication page of the Federal Register Notice (here) published today, OGD announced 28 new bioequivalence recommendations and revised 53 previously issued recommendations.  While the new and revised guidance documents appear on the listing of Product-Specific Guidances for Generic Drug Development (here), the links to the new and revised documents were not yet active at the time of this writing.

October 2019 Approval Actions and Receipts Reported by OGD

OGD reported the official approval actions, receipts, and Complete Response Letters for the first month of FY 2020.  There were 57 full approval actions and 8 tentative approval actions for a total of 65 approval actions for the month of October (we reported 52 and 9 actions respectively here), so it appears that there were some adjustments made to arrive at the final official numbers (along with some delay in reporting full approval actions).

With Thanksgiving on the Horizon, November ANDA Approvals Status

With the FDA reporting posted through November 18th, the OGD has issued full-approval actions for just twenty-four ANDAs and has issued tentative approval actions for two ANDAs.  Thanksgiving week is a notoriously slow week for approval actions due to the holiday and staff absences, so November looks like it will be a somewhat lean month for approvals. 

CVM Issues Guidance on Enforcement Policy Regarding the Compounding of Vet Drugs Using Bulk Drug Substances

In a guidance posted today, the Center for Veterinary Medicine (CVM) discusses its enforcement discretion policy for the use of bulk substances in the compounding of drugs used for non-food-producing animals and, to a more limited extent, for food-producing animals.

Unlike the statute and regulations for human drugs, there are no provisions for compounding animal drugs using bulk drug substances.  

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Lachman Consultants’ Team Teaches Young Professionals How Properly Preparing For and Addressing FDA Form 483 Ultimately Helps Save Patient’s Lives

(Westbury, NY – November 2019) Spanning approximately 120 minutes, part of the executive team from Lachman Consultant Services, Inc. (“Lachman Consultants”) guided 45 young professional engineers and chemists through an introduction to current Good Manufacturing Practices (“cGMP”) during ISPE’s 2019 Annual Meeting. As a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide,

Former FDA and Regulatory Experts from Lachman Consultants, Inc., to Serve as Panelists at AAM GRx & Biosimilars Meeting

(Westbury, NY— November 2019) Two top FDA and industry experts from Lachman Consultant Services, Inc., (“Lachman Consultants”) will be participating as panelists at The Association for Accessible Medicines (AAM) Generic (GRx) and Biosimilar (Biosims) Conference, also known as AAM GRx+Biosims, on November 4-6, 2019, at the Bethesda North Marriott Hotel & Conference Center in Bethesda,