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The Devil is in the Details: Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

By Roy Sturgeon, PhD. Sep 11, 2018 Compliance FDA

The FDA estimates that the burden of information collection under their newly revised draft Memorandum of Understanding (MOU) (here) and reporting to the FDA to be about 7600 hours per year per state (assuming approximately 2000 work hours per year; this equates to about four new employees per year per state). The FDA also estimates […]

Sep

Where There is Smoke, There is Fire!

By Eric Richmond, Ph.D. Sep 11, 2018 Compliance FDA Science & Technology

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.” A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ). This included […]

Sep

Changes to Drug Substance Draft Guidance Come to Town!

By Bob Pollock Sep 10, 2018 FDA Generics Regulatory Affairs Science & Technology

The GDUFA II reauthorization process involved a lot of agreements from the FDA. One of those agreements was for the Agency to publish a guidance on changes to drug substances that addressed the type of changes, their categories for submission (PAS, CBE, CBE-30, or annual report) and the necessary documentation that must be submitted to […]

Sep

Medical team sitting and discussing at table

History is written by people who attend meetings: especially when it comes to complex generics

By Pete Manger Sep 10, 2018 FDA Generics Regulatory Affairs

The GRx+Biosims Conference held in Baltimore, MD from September 5-7, had a session on the GDUFA II Pre-ANDA Program for Complex Products on the last day, presented by FDA. The presenter, Kris Andre, Associate Director of Regulatory Affairs, Office of Research and Standards, Office of Generic Drugs (OGD), discussed in detail the logistics and agency’s […]

Sep

Fast, Fast, Fast, Everybody Wants Fast – But There Could be a High Cost to Pay

By Bob Pollock Sep 10, 2018 FDA Generics Regulatory Affairs

I know that the flag was raised in victory when the first generic of EpiPen was approved. Not many people outside those familiar with the plight of complex generic products could understand how or why it took so long for a generic version of that product to make it through the approval process. This is […]

Sep

Bagpipe Player on Westminster Bridge London

GDUFA and BsUFA User Fees – Time to pay the piper!

By Janis Picurro Sep 07, 2018 FDA Regulatory Affairs

FDA’s User Fee Staff provided an overview of the progress and implementation of the first year of GDUFA II and BsUFA II user fees during the afternoon session of the second day of the GRx +Biosims Conference held at Baltimore, MD from September 5-7. The presentation recapped how the user fee structure for GDUFA II […]

Sep

Expedited Review, Priority Review, CTG – What’s the difference?

By Janis Picurro Sep 07, 2018 FDA Generics Regulatory Affairs

On the second day of the first annual 2018 GRx+Biosims Meeting in Baltimore, MD held from September 5-7, 2018, Kurt Karst, JD and Mark Schwartz, JD (Directors, Hyman, Phelps & McNamara, P.C) provided a very informative overview of cGMP trends and emerging legal issues concerning GDUFA and FDARA. The on-going modernization of the generic drug […]

Sep

Get Your Priorities Straight

By Pete Manger Sep 07, 2018 ANDAs Regulatory Affairs

The GRx+Biosims Conference held at Baltimore, MD from September 5-7, had a panel discussion regarding Successfully Managing Priority Generic Submissions on September 6th. The panel members were representatives from the industry. Discussions centered around the experience with priority submissions in the first year of GDUFA II. The consensus was that the submission of PFC (pre-submission […]

Sep

Informatics Initiative at the FDA: eCTD Metrics and Challenges

By Sharif Ahmed Sep 07, 2018 eCTD Regulatory Affairs

With eCTD submission format becomming binding as of May 5, 2017 for NDA, BLA, and ANDA and May 5, 2018 for Commercial IND and Master Files, the number of submissions to the FDA in eCTD format has significantly increased. According to Jonathan Resnick of the Office of Business Informatics (OBI), CDER received nearly 180,000 eCTD […]

Sep

Awareness And Precision Are Key To Manufacturing Data Integrity

By delia-admin Sep 07, 2018 Compliance Data Integrity Manufacturing Science & Technology

The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory. The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the […]

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The Lachman Blog

The Devil is in the Details: Requirements for State Boards of Pharmacy under the Draft Standard MOU Regarding 503A Compounding and Intrastate and Interstate Distribution

Where There is Smoke, There is Fire!

Changes to Drug Substance Draft Guidance Come to Town!

History is written by people who attend meetings: especially when it comes to complex generics

Fast, Fast, Fast, Everybody Wants Fast – But There Could be a High Cost to Pay

GDUFA and BsUFA User Fees – Time to pay the piper!

Expedited Review, Priority Review, CTG – What’s the difference?

Get Your Priorities Straight

Informatics Initiative at the FDA: eCTD Metrics and Challenges

Awareness And Precision Are Key To Manufacturing Data Integrity

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