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Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions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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05
Oct

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

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 […]

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27
Sep

Mullin and Booker Introduce Bill for e-labeling – New Round Begins

Senator Mullin and Booker yesterday introduced a bill (here ) to permit e-labeling (electronic package inserts) to eliminate paper waste and permit firms to provide the most updated information almost instantaneously.  There was also a press release (here ) that explained once more what has been explained a number of times in the past. This […]

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21
Sep

Get Ready for a New Approach to cGMP Inspections

Earlier this week, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here).  Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections.  The proposed Guidance […]

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