Regulatory Affairs

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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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05
Dec
Congress Questioning Delayed FDA Action on Phenylephrine - Lachman blog image

Congress Questioning Delayed FDA Action on Phenylephrine – What About Impact on Other Decongestants?

By    Dec 05, 2023    ANDAs NDA OTC Regulatory Affairs

In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]

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29
Nov

That DRESS Could Be Life Threatening! 

By    Nov 29, 2023    Adverse events ANDAs Labeling Regulatory Affairs

The FDA is warning about a serious and potentially fatal adverse event that has been reported with use of the antiseizure medications levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan).  The ADE, called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), is extremely rare and the “FDA’s cumulative review found 42 serious […]

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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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10
Nov

A New Approach to cGMP Inspections is Coming Soon. Our Contract Pharma Article Gives You a Preview.

By    Nov 10, 2023    Biosimilars cGMPs FDA Guidance Inspections Regulatory Affairs

Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry.” The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA. Are you among the many […]

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01
Nov
Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 –Let's Take a Look

Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 – Let’s Take a Look!

By    Nov 01, 2023    ANDAs Approvals FDA Generics OGD Regulatory Affairs Statistics

First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]

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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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