Compliance

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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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11
Dec
Manual Integration of Chromatographic Data - Lachman Consultants Blog

Manual Integration of Chromatographic Data

By    Dec 11, 2023    Compliance Data Integrity Regulatory Affairs

This blog post focuses on the unprocessed, processed, and re-processed chromatographic data (e.g., data generated using chromatographic instruments such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Performance Liquid Chromatography (UPLC), etc.). To some operators, the unprocessed chromatographic data might not be recognized, nor would they raise any concerns with the validity of the […]

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08
Dec
Changes Coming for Cosmetics Previewed at the FDLI Enforcement, Litigation, and Compliance Conference - Lachman Blog

Changes Coming for Cosmetics Previewed at the FDLI Enforcement, Litigation, and Compliance Conference

By    Dec 08, 2023    Compliance Cosmetics

At Lachman Consultant Services, we pride ourselves on being a preferred partner for quality, compliance, and regulatory consulting services for the life-sciences sector. However, we provide services to every sector regulated by the FDA except food and tobacco, and there are a lot of changes coming down the pike in the regulation of cosmetic products […]

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06
Dec

Reconsideration: Non-Sterile Drug Manufacture – Don’t Let It Bug You!

By    Dec 06, 2023    ANDAs Compliance Generics NDA OTC

The bulk of microbiology attention in the drug manufacturing world is laser focused on sterile drug products and the myriad steps needed to aseptically manufacture them. That is certainly with good reason as those drug products carry the highest patient risk should there be microbial contamination. One aseptic manufacturing misstep and the consequences could be […]

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22
Nov

Establishing a CCS Foundation for Cleaning Validation 

By    Nov 22, 2023    ANDAs Biologics Biosimilars BLA Cleaning validation Compliance Contamination Control Strategy NDA OGD Regulatory Affairs

Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language.  Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]

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08
Nov
Cosmetic Facility Registration and Listing Gets 6-Month Reprieve

Cosmetic Facility Registration and Listing Gets 6-Month Reprieve

By    Nov 08, 2023    Compliance Cosmetics

The FDA issued a guidance today entitled Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (here) announcing a 6-month period during which the FDA will not take compliance actions against a company for failing to meet the cosmetic listing and facility registration requirements. According to the FDA, the policy is designed to […]

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30
Oct

EU Issues Communication Addressing Medicine/Drug Shortages 

By    Oct 30, 2023    ANDAs Biologics Biosimilars BLA Compliance NDA OGD Regulatory Affairs Supply chain

The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem.  The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here).  This is a deep dive […]

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30
Oct
cyborg robot hand changes text cube - ai concept

Cross-Agency Cooperation Takes Next Step in Artificial Intelligence Maturity 

By    Oct 30, 2023    Artificial intelligence Compliance

The artificial intelligence paradigm shift is taking what was once a wish into reality, specifically, cross-regulatory agency coordination and harmonization.  The latest publication in this area is a joint effort of the U.S. Food and Drug Administration (FDA), U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada to define guiding principles in AI […]

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25
Oct
Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

By    Oct 25, 2023    Compliance Data Integrity Drug Shortages FDA Supply chain

Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]

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