FDA Archives - Page 19 of 46 - 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

FDA Updates March 2022 Metrics – What Happened to April?

By Bob Pollock May 03, 2022 ANDAs FDA Regulatory Affairs Statistics

The March statistical update to the Generic Drugs Program Activities Report – Monthly Performance brings the refuse-to-receive (RTR) count back to a manageable number of three, which has been seen every month so far this FY except for last month, which saw triple that number. The OGD also acknowledged sixty‑two ANDAs in March. Other metrics […]

Apr

Complex Products – What Does OGD Look at When Evaluating Comparability?

By Bob Pollock Apr 27, 2022 Combination Products Drug-device FDA

At the Generic Drug Forum virtual SBIA event that is still ongoing, Andrew J. Fine, PharmD, BCPS, Senior Advisor, Division of Clinical Review, Office of Safety & Clinical Evaluation, Office of Generic Drugs, provided a look at the type of information that needs to accompany a complex product (particularly a drug device combination) to establish […]

Apr

Official Approval Numbers, CRLs, and New ANDAs for March Hit the OGD Stats Report

By Bob Pollock Apr 21, 2022 ANDAs FDA Generics OGD Regulatory Affairs Statistics

If we say so ourselves, we totally nailed the full-approval actions for March when we reported the unofficial number at sixty-three (see previous post here) but, at the same time, we missed big time on the tentative-approval actions, which we reported at four – well, the official TA approval actions were just reported at eighteen! […]

Apr

More ANDAs Awaiting FDA Action

By Bob Pollock Apr 20, 2022 ANDAs FDA OGD Regulatory Affairs Statistics

According to the Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance published yesterday, the Office of Generic Drugs is looking at over 1,712 ANDAs that are pending Agency action. While down a bit from the 1,749 reported at the end of the first quarter, the number jumped from the end of […]

Apr

A Peek at the OGD April Approval Actions

By Bob Pollock Apr 19, 2022 ANDAs Approvals FDA Generics Regulatory Affairs

April showers bring May flowers, as the saying goes. Well, April thus far has not showered down approvals as, halfway through the month, the OGD stands at twenty‑one full‑approval actions and three tentative‑approval actions. If the trend continues through the end of the month, we could be heading for a month with less than fifty […]

Apr

Continuous Manufacturing and its Regulatory Challenge Image

Particles, Particles, Particles – Some Have a Game Plan

By Rebecca Welton Apr 19, 2022 FDA Particulates Science & Technology Sterile products

During day 2 of the PDA conference, there was a very enlightening session called “Game Plan: Progress to the Next Stage of Contamination Control.” Anne Marie Dixon-Heathman, President of Cleanroom Management Associates, Inc., gave a presentation called “Contamination Control: A new approach to the Reduction of 5-micron particles.” She discussed product loss resulting from five-micron […]

Apr

February 2022 OGD Stats Come into View as Agency Updates Report

By Bob Pollock Apr 19, 2022 ANDAs FDA Generics Regulatory Affairs Statistics

The OGD updated its usual February statistical report late yesterday (April 18, 2022) to complete the month’s reporting. To start out with a bit of a startling number, February saw nine ANDAs issued refuse‑to‑receive (RTR) letters. This is triple the number in any month this FY (only three RTRs were reported in each of the […]

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 […]

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FDA

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

FDA Updates March 2022 Metrics – What Happened to April?

Complex Products – What Does OGD Look at When Evaluating Comparability?

Official Approval Numbers, CRLs, and New ANDAs for March Hit the OGD Stats Report

More ANDAs Awaiting FDA Action

A Peek at the OGD April Approval Actions

Particles, Particles, Particles – Some Have a Game Plan

February 2022 OGD Stats Come into View as Agency Updates Report

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?

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