Emerging Technology Archives - Lachman Consultant Services, Inc.

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

By Webmaster Lachman Dec 08, 2020 Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

Feb

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

By Amy Schutte Feb 24, 2020 ANDAs Approvals Bioanalytical Bioequivalence Biologics Brand Name Drugs CBER CDER CMC Complex Generics Emerging Technology FDA Generics NDA New Drugs Regulatory Affairs Science & Technology

The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here). A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]

Feb

Hand Holding a Chemical Solution Test-tube in a bio-Chemistry DNA Research Laboratory

CBER Publishes a Boatload of New Gene Therapy Guidances

By Keith Webber Feb 14, 2020 Accelerated Approval Analytical Methods Bioequivalence Biologics BLA CBER Chemistry CMC Combination Products Compliance Emerging Technology FDA Guidance New Drugs Quality Regulatory Affairs

January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents! A total of six final guidelines and one draft guideline on GT products were issued. These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

Feb

Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

By Amy Schutte Feb 12, 2020 ANDAs BLA CBER CDER Compliance Emerging Technology Enforcement FDA Generics IND NDA New Drugs OGD Quality Regulatory Affairs

The FDA’s Office of Pharmaceutical Quality (OPQ) is the group within the FDA that defines the quality requirements for all human drugs under its umbrella (filed as NDAs, ANDAs, BLAs, 351(k)/Biosimilars, and OTC products). The group issued its 2019 Annual Report just this month (read the full report here) that includes a look back […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Nov

The Question of Generics and Emerging Technology

By Amy Schutte Nov 05, 2019 ANDAs Emerging Technology FDA Generics Regulatory Affairs

At the Association for Accessible Medicines GRx-Biosims conference currently ongoing in Bethesda, FDA called on Generic firms to be involved and participate in innovation and FDA’s Emerging Technology initiative. We heard that innovation was not something that should be limited to just Brand Companies. But, in the field of Generics, where Q1/Q2 and sameness or […]

Emerging Technology

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

CBER Publishes a Boatload of New Gene Therapy Guidances

Promoting Confidence Through Product Quality – OPQ 2019 Annual Report

Hope at This Time of Giving Thanks

The Question of Generics and Emerging Technology

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