NDA Archives - Page 11 of 25 - Lachman Consultant Services, Inc.

Hold On! That Previously Acceptable Level of Nitrosamine in Your Product is No Longer Acceptable!

By Bob Pollock May 06, 2022 ANDAs Compliance FDA NDA Nitrosamines Regulatory Affairs Science & Technology

Yesterday, the Agency expressed confidence that manufacturers of varenicline tablets containing the N‑nitroso-varenicline impurity can meet the FDA’s original acceptable intake limit of 37 ng or less per day. Their statement read: “FDA is now confident in manufacturers’ ability to supply patients with varenicline containing the N-nitroso-varenicline impurity at or below the agency’s acceptable intake limit […]

May

Data Integrity Reviewed at Generic Drug Forum

By Bob Pollock May 02, 2022 ANDAs BLA Data Integrity Generics NDA Regulatory Affairs

Data integrity (DI) has been a problem for as long as I remember, and my memory goes way back. The first real exposure I had to DI issues dates to the early days of Hatch-Waxman, passage of which had led to the generic drug scandal of the late 1980s. I could write a book about all […]

Apr

FDA Issues Final Guidance on BA Studies in INDs and NDAs

By Bob Pollock Apr 14, 2022 Bioavailability FDA IND NDA

Today, the FDA published the final guidance titled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations” (here). The final guidance comes after the FDA incorporated comments that it received on the draft of the same name issued on February 26, 2019. That 2019 draft guidance replaced the March 2014 guidance titled “Bioavailability and Bioequivalence Studies […]

Apr

The Hunt for the Elusive TE Rating for Certain 505(b)(2) Applications – So What’s Holding Up the FDA?

By Bob Pollock Apr 11, 2022 505(b)(2) FDA NDA Therapeutic equivalence ratings

The 505(b)(2) application is really a hybrid of a New Drug Application (NDA) approved under Section 505C of the FFDCA Act (the Act) and an Abbreviated New Drug Application (ANDA) which is approved under Section 505(j) of the Act. The (b)(2) pathway was a creation born out of the Hatch-Waxman Act of 1984. It permits […]

Mar

The FDA Inactive Ingredient Database (IID) - Lachman Consultants

The Agency Requests Comments on IID – Will Changes Help or Hinder Drug Development?

By Bob Pollock Mar 21, 2022 ANDAs FDA Generics Inactive ingredients NDA Regulatory Affairs

In the prepublication of the Federal Register today, the FDA asked for comments on issues related to trying to reduce the confusion on maximum daily intake (MDI) and maximum daily exposure (MDE) limits in its Inactive Ingredient Database (IID). The industry uses the IID to identify the level of inactive ingredients that may be safely […]

Mar

If You Have a Flair for the Plair, Your Final Guidance Has Just issued!

By Bob Pollock Mar 02, 2022 ANDAs BLA FDA NDA Regulatory Affairs

Yesterday, the FDA issued its final guidance on the Pre-Launch Activities Importation Requests (PLAIR), a process that permits importation of unapproved NDA, ANDA and CDER-regulated BLA products into the United States in anticipation of imminent approval. The original draft guidance was issued on July 24, 2013. The FDA says that it considered comments received on […]

Feb

Recommended Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is Non-Binding

By Bob Pollock Feb 15, 2022 ANDAs BLA Compliance FDA NDA Regulatory Affairs

As a result of the considerable number of comments received on the draft guidance Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry (here), particularly the number of those related to timing of the reports (originally slated for 2/15/22), the FDA […]

Feb

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

By Rebecca Welton Feb 01, 2022 CARES Act Compliance FDA Generics NDA OTC Regulatory Affairs

Back in November 2021, the Lachman blog brought your attention to the changes coming with the new FDA reporting requirements that were instituted under the March 2020 CARES Act (section 3112(e)) when it was reported at the AAM GRx-Biosims conference. This new law, enacted for COVID‑19 response and relief, includes “enhanced” abilities for the FDA […]

Dec

IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

By Bob Pollock Dec 23, 2021 ANDAs FDA NDA Safety

The IPledge Risk Evaluation and Mitigation (REMS) program was designed to address the significant potential for serious birth defects should a pregnancy occur during treatment with the drug isotretinoin which is used to treat acne. The program covers both males and females, since isotretinoin can be passed through the semen of males if the male […]

Nov

AAM’s GRx-Biosims Day 2 – Afternoon Sessions

By Bob Pollock Nov 10, 2021 ANDAs BLA FDA Generics NDA Regulatory Affairs

The afternoon sessions of the conference that I was able to attend included a discussion of Combination Products and Similarity, and two legal-based sessions, one on Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2) and the other on Generic Drug Case Law. The combination product similarity session described the various permutations of the sameness […]

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NDA

Hold On! That Previously Acceptable Level of Nitrosamine in Your Product is No Longer Acceptable!

Data Integrity Reviewed at Generic Drug Forum

FDA Issues Final Guidance on BA Studies in INDs and NDAs

The Hunt for the Elusive TE Rating for Certain 505(b)(2) Applications – So What’s Holding Up the FDA?

The Agency Requests Comments on IID – Will Changes Help or Hinder Drug Development?

If You Have a Flair for the Plair, Your Final Guidance Has Just issued!

Recommended Reporting Date for 2020 Amounts of Listed Drugs and Biological Products is Non-Binding

CARES Act Manufacturing Quantities Reporting Requirement – Better Sharpen Your Pencils!

IPledge Isotretinoin REMS Prompts FDA Flexibility and Plea to Manufacturers

AAM’s GRx-Biosims Day 2 – Afternoon Sessions

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