Petitions Archives - Lachman Consultant Services, Inc.

Petition Tests OGD Guidance on Use of Males and Females in BE Study

By Bob Pollock May 19, 2023 ANDAs Bioequivalence Generics OGD Petitions Regulatory Affairs

A Citizen Petition submitted recently by McDermott Will & Emory (here) on behalf of Vanda Pharmaceuticals requests that the FDA “revoke approval of Abbreviated New Drug Application (ANDA) No. 211654, submitted by MSN Pharmaceuticals Inc. (MSN), for 20 mg tasimelteon capsules, and order a recall of any product that has been distributed under ANDA No. 211654 (if any) […]

Oct

OGD Published GDUFA III Commitment Letter

By Bob Pollock Oct 31, 2021 ANDAs DMFs FDA GDUFA Generics Inspections OGD Petitions Regulatory Affairs Suitability Petitions User Fees

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

Oct

FDARA Report 2021 on ANDA Suitability Petition Activity

By Bob Pollock Oct 18, 2021 ANDAs FDA Petitions Regulatory Affairs

Well, we have been seeing certain information on ANDA suitability petitions since FDARA passed, but only the information required by the Act. The FDA reports a separate list of petitions that have been filed, those that are pending, or those that have been acted upon. Unfortunately, according to the FDA page where the list resides […]

May

Is the New Proposed Legislation (S-1462) Regarding ANDA Suitability Petitions as Good as it Sounds?

By Bob Pollock May 03, 2021 FDA Generics Petitions Regulatory Affairs

The ANDA suitability petition process has been languishing for years. Over the years, we have drafted many posts (here, here, here, here, here, here, here, and here, among others) regarding the FDA’s failing to act on what is a statutorily mandated ninety-day time period for approving or denying an ANDA suitability petition. Today, I read […]

Feb

Suitability Petitions – A Look at Recent Activity!

By Bob Pollock Feb 18, 2021 FDA Generics Petitions Regulatory Affairs

Let me start off by saying you all know that I am a bit bitter about the lack of activity on the 505(j)(2)(C) ANDA suitability petitions. So, in an attempt to soothe my nerves and calm myself down, I looked back to January 1, 2020 to see how many ANDA suitability petitions have been filed […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Jul

Potential Label Carve Out to Antidepressant Appears OK to FDA

By Bob Pollock Jul 23, 2019 FDA Generics Labeling Petitions Regulatory Affairs

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]

Petitions