Controlled correspondence Archives - Lachman Consultant Services, Inc.

FDA SBIA Generic Drug Forum

By Rebecca Welton Apr 16, 2024 ANDAs Bioequivalence Controlled correspondence Generics OGD PSGs Regulatory Affairs

What is the answer to the question? Apparently, at the FDA’s Center for Drug Evaluation and Research (CDER) Small Business Industry Assistance (SBIA) Generic Drug Forum for 2024 (held April 10-11), it was Controlled Correspondence (CC). The FDA conducted two presentations exclusively on CCs and responded with that answer on more questions than not throughout […]

Aug

Surviving the Perils of Submitting Controlled Correspondences (Part 2)

By Jennifer Leaming and Rebecca Welton Aug 25, 2023 ANDAs Controlled correspondence FDA Generics

In Part 1, we focused on drafting the Controlled Correspondence and tips for formatting and presenting the correspondence, but, after submission, the CC must be accepted by the coordinator to be placement in the queue for review. The office has been very strict, perhaps rightly so, but there have been a few headscratchers too. Some examples […]

Aug

Surviving the Perils of Submitting Controlled Correspondences (Part 1)

By Jennifer Leaming and Rebecca Welton Aug 24, 2023 ANDAs Controlled correspondence FDA Generics

Of the many benefits that have come from the Generic Drug User Fee Act (GDUFA) over the years, one has been the addition of response times for the FDA to answer Controlled Correspondences (CCs) that were first negotiated under GDUFA II. The Agency issued an FDA CC guidance, which was finalized in December 2020. Having a […]

Dec

Revised Guidance on Controlled Correspondence for ANDAs

By Bob Pollock Dec 21, 2022 ANDAs Controlled correspondence FDA Regulatory Affairs

The FDA published a revised guidance issue today (here) that revises a December 2020 guidance on Controlled Correspondence (CC) by the Office of Generic Drugs. This December 2020 guidance is being updated to reflect the new provisions of GDUFA III and its commitment letter relative to the submission of CC. “This guidance provides information regarding the […]

Apr

Examples of Many of the Catch 22s of Controlled Correspondence with the FDA

By Bob Pollock Apr 12, 2021 ANDAs Controlled correspondence FDA Generics Regulatory Affairs

Okay, so you want to bring a product back from the dead. That is, you want to file an ANDA for an older discontinued product without competition and with no designated reference listed drug (RLD) or reference standard (RS) published in the Orange Book (OB). Oh yeah, and you also want to start a development […]

Dec

OGD Finalizes Controlled Correspondence Guidance

By Bob Pollock Dec 16, 2020 ANDAs Controlled correspondence Guidance OGD Regulatory Affairs

While many in the industry have complained about the handling of controlled correspondences (CCs), the numbers of CCs submitted in a given month continues to rise as it has every fiscal year since the process was formalized under GDUFA I. Complaints of non-answers to questions, unclear answers, and just flat-out denials of acceptance of CCs […]

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 […]

Nov

Audience Perspective – Both Sides of the Controlled Correspondence Story; One Common Problem

By Amy Schutte Nov 06, 2019 Controlled correspondence FDA Generics Regulatory Affairs

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, members of the FDA and industry came together to present opinions and discuss the Controlled Correspondence process. Controlled Correspondence (CC) between the FDA and industry is very much like an important pen pal relationship (where you only write to each other regularly, but […]

Controlled correspondence