Regulatory Affairs Archives - Page 30 of 163 - 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 […]

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

The Future of Us

By Dave Lonza Apr 28, 2022 FDA Regulatory Affairs Science & Technology

As our world spins toward the highly anticipated “new normal,” pharma and related industry conferences in the last few months have shown us that the new normal will be anything but business as usual. Instead, we are witnessing an accelerated adoption of advanced new technologies that many of us had previously associated with the IT […]

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

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

MaPP Out – What Constitutes a Complex Generic Drug? FDA Explains

By Bob Pollock Apr 15, 2022 ANDAs Complex products FDA Generics Regulatory Affairs Science & Technology

On April 15, 2022, FDA published a Manual of Policy and Procedures (MaPP) that outlines the FDA thinking on what constitutes a complex drug product for purposes of classification. A MaPP, as you know, is not an industry tool, but rather an instruction to FDA staff as to the policy and procedure that they utilize […]

Apr

PDA Day 2 – Vaccine Interest Group Update

By Dave Lonza Apr 08, 2022 Compliance FDA Regulatory Affairs Science & Technology

For the first time in two years, a number of Lachman Consultants Team were able to attend the PDA Annual conference in Dallas, Texas this week. At this meeting, there was an opportunity for many of the PDA Interest Groups (IGs) to have face-to-face discussions that had, for the last two years been virtual due […]

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Regulatory Affairs

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

FDA Updates March 2022 Metrics – What Happened to April?

Data Integrity Reviewed at Generic Drug Forum

The Future of Us

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

February 2022 OGD Stats Come into View as Agency Updates Report

MaPP Out – What Constitutes a Complex Generic Drug? FDA Explains

PDA Day 2 – Vaccine Interest Group Update

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