Biologics

12
Feb
Metal clean shelves in market. 3d rendering

The “Hows” of Drug Shortages 

If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages.  The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well.  With different individuals providing […]

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25
Jan
The Court Case That Could Have Implications Beyond Its Borders - Lachman Blog

The Court Case That Could Have Implications Beyond Its Borders

This morning, when I read a Decision and Order issued by the United States Court of Federal Claims regarding a motion that was granted in part, denied in part, and filed on behalf of a pharmaceutical company and the FDA, the hair on the back of my neck stood on end. Now, I must state […]

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27
Dec
The Eyes Have it - Lachman Consultants Blog

The Eyes Have it!

On December 27, 2023, the FDA released a revised draft version of its October 2023 guidance titled Quality Considerations for Topical Ophthalmic Drug Products: Guidance for Industry. This revised draft, of the same name, outlines most of what was covered in the October draft guidance; however, it does include some clarifications and some additional information. The […]

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19
Dec
CBER Orphan Drug Approvals for 2023 - Lachman Consultants

CBER Orphan Drug Approvals for 2023

According to an updated post on the Center for Biologics Evaluation and Research (CBER) webpage, there were twelve Biologics License Applications (BLAs) approved for products that had orphan drug (OD) status. Just to cite a few: Two were for treatment of sickle cell disease (SCD). One was for enzyme replacement therapy (ERT) in adult and […]

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12
Dec

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

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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22
Nov

Establishing a CCS Foundation for Cleaning Validation 

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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30
Oct

EU Issues Communication Addressing Medicine/Drug Shortages 

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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24
Oct

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

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 […]

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