Compliance

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21
Feb

Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

By and    Feb 21, 2024    Compliance Inspections News Nitrosamines Quality issues

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

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05
Feb
Helpful Tips

AAM Annual Meeting Regulatory and Science Meeting

By    Feb 05, 2024    ANDAs Compliance Data Integrity FDA Generics Labeling OGD Regulatory Affairs

A presentation delivered by Office of Generic Drugs Director, Iilun Murphy, M.D. during the members-only Regulatory and Policy meeting at the start of AAM’s annual meeting provided seven tips for ANDA sponsors with regard to their ANDA submissions: Submit a clear cover letter. Describe what is being submitted. State whether the submission includes a labeling […]

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01
Feb

FDA Publishes Medical Devices Quality System Regulation Amendments Final Rule 

By    Feb 01, 2024    Compliance Device Regulatory Affairs

The 101-page Federal Register (FR) document published on the prepublication page of the FR today (here) describes the rule in detail and provides responses to comments received by stakeholders on the proposed final rule.  The FDA states:  “We are amending part 820, primarily to incorporate by reference ISO 13485, Medical Devices—Quality Management System Requirements for Regulatory Purposes.  […]

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17
Jan
Office of Compliance Issues FY 2023 Annual Report - Lachman Blog2

FDA’s Office of Compliance Issues FY 2023 Annual Report

By    Jan 17, 2024    Compliance FDA Regulatory Affairs Statistics Unapproved Drugs

Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]

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08
Jan
Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete

Are Chromatograms Identified as “Incomplete Data” in Empower Really Incomplete?

By    Jan 08, 2024    Compliance Data Integrity Lab Equipment

Have you ever found an Empower 3 chromatogram with no plot and the message “Incomplete Data”? You might have assumed that there was a system glitch, resulting in no data being acquired for the injection. However, data may have been acquired and can only be viewed if you have the appropriate permission(s). A search of the […]

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02
Jan
Good Guidance Practices – FDA Wants Your Input_blogimage

Good Guidance Practices – FDA Wants Your Input!

By    Jan 02, 2024    ANDAs Biosimilars BLA Compliance FDA Generics Guidance Document Development Regulatory Affairs

In 2011, the FDA published the draft “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency” (here) that established the way that the FDA would prioritize, develop, and release guidances in draft or final, and identified two levels of guidances, a so-called Level 1 and Level 2. A Level 1 guidance document is one […]

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15
Dec

What is Your GxP Computer System Audit Trail Telling You? 

By    Dec 15, 2023    Compliance Data Integrity Regulatory Affairs

Have you reviewed your audit trail lately?  What is it telling you and your team?  We all understand the importance of audit trails, and companies review audit trails in one way or another, but does your staff truly understand what the audit trail is stating?  Processes in a GxP environment should be developed and implemented […]

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12
Dec
More History of the 503B and 503A Bulk Drug Substance Lists Significant and Welcomed Changes_LachmanBlog

More History of the 503B and 503A Bulk Drug Substance Lists: Significant and Welcomed Changes?

By    Dec 12, 2023    Compliance Compounding FDA

Last week, the FDA has announced the availability of two draft Guidances for Industry regarding compounding of human drugs: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (here); and Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and […]

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12
Dec

Revision 1 of Risk information in Promotional Materials and Ads Hits the Street 

By    Dec 12, 2023    ANDAs Biologics Biosimilars BLA Compliance Generics Labeling NDA OGD Regulatory Affairs

Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here).  This Guidance covers the following four topics:  Providing quantitative efficacy or risk information for the control group, when applicable;  Presenting probability information in terms of absolute frequencies, percentages, and relative […]

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