Bioequivalence

20
Aug

Big Day for FDA and OGD Bioequivalence Information

Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here).  This 42‑page guidance supersedes the December 2013 draft guidance of the same name.  The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]

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19
Jan

Outlining COVID-19 Safety Expectations for ANDA BE Studies

On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”.  This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency.  As is no surprise, FDA clearly […]

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03
Jun
New and Revised Bio Guidances Issued by OGD Image

New and Revised Product Specific Bioequivalence Recommendations List Update

The FDA announced today the addition of 25 new bioequivalence (BE) recommendations and has issued revisions of 24 previous recommendations.  FDA continues its efforts in getting ahead of the curve trying to issue BE recommendations for “(1) new chemical entities and (2) approved on or after October 1, 2017, at least 2 years prior to […]

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29
Apr

BE Studies and COVID 19 Pandemic – What’s an Applicant To Do?

Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies.  The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]

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24
Feb
October Approvals

Glimpses of What’s Ahead – FY 2019 GDUFA Science and Research Report

The FDA issued its Fiscal Year (FY) GDUFA Science and Research Report last week (read the full report here and the awarded research contracts and grants here).  A review of the innovative scientific focus areas helps those of us in the industry to get a sense of where the FDA is headed in support of […]

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20
Feb
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Regulatory Affairs and the CMO Factor

The use of contract manufacturers for the production of approved drug products has become more and more commonplace, particularly with the steady increase through the years of virtual pharmaceutical companies, a business model where the majority of the drug development and production work is outsourced to third parties as needed.  While the use of a […]

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18
Feb
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Out-of-Specification Investigations – Lessons Learned, or Not?

The FDA Guidance for Industry, Investigating Out‑of-Specification (OOS) Test Results for Pharmaceutical Production, was published in October 2006 (here).  The pharmaceutical industry has had about 14 years to learn how to comply to this guidance.  A quick survey of recent Form 483s and Warning Letters would indicate that there is still much to be learned […]

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14
Feb
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CBER Publishes a Boatload of New Gene Therapy Guidances

  January was a gangbuster month for the FDA’s Center for Biologics Evaluation and Research (CBER) with regard to publication of gene therapy (GT) guidance documents!  A total of six final guidelines and one draft guideline on GT products were issued.  These included: Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug […]

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05
Feb
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FDA and FTC Announce a Coordinated Plan for Advancing Competition in the Biologic Drug Marketplace

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement on Monday, February 3, 2020 (here) regarding their collaborative plans to advance competition in the biologics market.  This joint effort is intended to address misinformation and anti-competitive behavior that may impede competition between biologic drug products.  A significant focus […]

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