2016 - Page 18 of 20 - Lachman Consultant Services, Inc.

FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

By Bob Pollock Feb 18, 2016 Compliance FDA Generics Regulatory Affairs Science & Technology

Today, the FDA published its final updated Guidance entitled, Immunogenicity – Related Considerations for Low Molecular Weight Heparin (LMWH) (here). The document provides advice on the proper characterization of active ingredient sameness (for ANDAs), as well as considerations for immunogenicity testing for such products. The document provides guidance for NDA holders (for new products or […]

Feb

DMF Completeness Assessment Guidance for Generics Issues

By Bob Pollock Feb 12, 2016 FDA Generics Regulatory Affairs

Well, we did not have to wait long after the blog post on upcoming Guidance documents for the DMF Completeness Assessment (CA) Guidance to issue (here). The document begins with a concise discussion of the GDUFA requirements for DMFs submitted to support approval of generic applications, including the requirements for fees, what triggers a […]

Feb

PDUFA Fees – 505(b)(2) – Full Fee or Half Fee – Be Sure to Budget for the Worst Case

By Bob Pollock Feb 08, 2016 FDA Regulatory Affairs

Most know that when a 505(b)(2) contains the results of a clinical study other than a bioequivalence study, the application will be assessed a full PDUFA user fee. However, did you know that if you file a 505(b)(2) application that relies on published clinical studies, your application may also be subject to the full fee?

Feb

January 2016 Approvals Update and Receipts

By Bob Pollock Feb 02, 2016 FDA Generics Regulatory Affairs

The number of approvals reported yesterday was revised upwards by 1 to 43, according to the Office of Generic Drugs (OGD).

Feb

January’s Big Chill Places Some Strain on Approval Actions

By Bob Pollock Feb 01, 2016 FDA Generics Regulatory Affairs

The Washington DC. / Maryland “snowmageddon” event causing the closure of the Federal Government for a few days may have resulted in a dip in ANDA approvals in the first month of calendar year 2016. The Office of Generic Drugs (OGD) fully approved 42 ANDAs and tentatively approved 17 ANDAs in January. Four months […]

Jan

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

By Linda Evans O'Connor Jan 28, 2016 News Uncategorized

When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products. What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS). Running applications in the cloud is a relatively new […]

Jan

Add One More to the List of Revised BE Guidance on Extended-Release Products

By Bob Pollock Jan 28, 2016 FDA Generics Regulatory Affairs

FDA issued a revised bioequivalence recommendation for Lamotrigine ER Tablets calling on the firms to perform fasting and fed bioequivalence studies on the 200 mg tablet and a fasting study on the 50 mg. Neither of these products are the highest or lowest strength in the product strength range of 25 mg to 300 mg […]

Jan

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

By Linda Evans O'Connor Jan 27, 2016 Compliance FDA Generics Regulatory Affairs

Jan

Goal Dates – the Snow Does Not Care!

By Bob Pollock Jan 25, 2016 Compliance FDA Generics Regulatory Affairs Uncategorized

While 26-30 Inches of snow fell in the Washington DC corridor, the brunt of the storm has hit the FDA with offices being closed today while the dig out continues. For those of you who had GDUFA, PDUFA goal dates, or TADs scheduled for today, you may have to wait a day or two more […]

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FDA Finalizes Guidance on Low Molecular Weight Heparin Characterization and Immunogenicity Considerations

DMF Completeness Assessment Guidance for Generics Issues

More on the New Guidance Documents FDA Plans to Issue in 2016

PDUFA Fees – 505(b)(2) – Full Fee or Half Fee – Be Sure to Budget for the Worst Case

January 2016 Approvals Update and Receipts

January’s Big Chill Places Some Strain on Approval Actions

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

Add One More to the List of Revised BE Guidance on Extended-Release Products

Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

Goal Dates – the Snow Does Not Care!

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