Biologics Archives - Page 4 of 12 - Lachman Consultant Services, Inc.

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

By Bob Pollock 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 […]

Nov

Establishing a CCS Foundation for Cleaning Validation

By Paul Dexter 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 […]

Oct

EU Issues Communication Addressing Medicine/Drug Shortages

By Patrick Day 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 […]

Oct

Dissemination of Articles and Study Results, New Revised Q&A Draft Guide May Provide Better Direction

By Bob Pollock Oct 24, 2023 Biologics Biosimilars BLA NDA

Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]

Oct

New Address for Courier Delivery for User Fees - LachmanConsultantsv2

New Address for Courier Delivery for User Fees – Take Note!

By Bob Pollock Oct 06, 2023 ANDAs Biologics Biosimilars BLA Generics NDA OGD

While most sponsors make direct payments for their user fees, if you are one of those that like to send the money via check or other non-electronic method, better make sure you take note of the new address for delivery of such payments. “The Food and Drug Administration (FDA) is providing notice that the courier […]

Oct

GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections

By Matt Taylor Oct 05, 2023 Biologics Biosimilars BLA NDA

On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry. Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon. Dr. Downey opened […]

Sep

Are You Using the New FDA Form 356h?

By Bob Pollock Sep 25, 2023 ANDAs Biologics Biosimilars BLA Generics NDA

The new Form FDA-356h was released in July 2023. The FDA’s expectation is that the newly revised form (which has an expiration date of March 31, 2026) should be utilized when submitting new drug applications, abbreviated new drug applications, and biologics license applications for human use. The new form can be downloaded from a link that […]

Aug

Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

By Binh Nguyen and Matt Taylor Aug 24, 2023 Biologics Data Integrity FDA Generics Inspections Medical Devices Pharmaceutical industry

As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]

Aug

Something’s Not Right Here – How Does This Happen?

By Bob Pollock Aug 15, 2023 ANDAs Biologics Biosimilars BLA Compliance FDA Generics NDA Regulatory Affairs Unapproved Drugs

On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing. On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required). Congress has been pushing […]

Aug

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

By Rebecca Welton Aug 04, 2023 Analytical Methods ANDAs Applications Bioanalytical Biologics cGMPs CMC Compliance FDA Generics Guidance for Industry Industry Manufacturing NDSRI New Drugs Nitrosamines OTC Pharmaceutical industry Quality Regulatory Affairs Risk Management Safety

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products. As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

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Biologics

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

Establishing a CCS Foundation for Cleaning Validation

EU Issues Communication Addressing Medicine/Drug Shortages

Dissemination of Articles and Study Results, New Revised Q&A Draft Guide May Provide Better Direction

New Address for Courier Delivery for User Fees – Take Note!

GRx+Biosims Presentation Recap: FDA Expectations for Biosimilar Manufacturing Inspections

Are You Using the New FDA Form 356h?

5 Reasons Why You Should Perform a Mock Inspection Now

Something’s Not Right Here – How Does This Happen?

New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

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