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Articles (419)

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1-10 of 419 results for FDA issues

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Select article: Statistical Issues in Biologics Submissions to the FDA

Retricted access

Research article

First published 1996-10

Statistical Issues in Biologics Submissions to the FDA

Cornelius J. Lynch, Peter A. Lachenbruch

Therapeutic Innovation & Regulatory Science

Select article: Eye Drop Quality Issues: Can the FDA See This One Through?

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Editorial

First published 2024-11

Eye Drop Quality Issues: Can the FDA See This One Through?

Lyla R. White, C. Michael White

Annals of Pharmacotherapy

Select article: Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

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Research article

First published 1996-10

Statistical Issues on the FDA Conjugated Estrogen Tablets Bioequivalence Guidance

Jen-pei Liu, Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

Select article: Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study

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Research article

First published 2019

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study

Shray Bablani, Manthan D. Janodia

Therapeutic Innovation & Regulatory Science

Select article: A narrative review of illegal online pharmacies and contemporary issues with restricting FDA-approved medication access

Open access

Review article

First published 2023

A narrative review of illegal online pharmacies and contemporary issues with restricting FDA-approved medication access

Zarnab Jillani, Lauren Reinhard, John Hertig

The Journal of Medicine Access

Select article: Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

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Research article

First published 2016-5

Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

Liqing Wang, Hang Zheng, Xiaohong Ren [...]

Therapeutic Innovation & Regulatory Science

Select article: FDA Issues Guidance on Financial Disclosure

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Research article

First published 2013-06

FDA Issues Guidance on Financial Disclosure

Biotechnology Law Report

Select article: FDA Issues Draft Guidance on LDTs

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News

First published 2014-10

FDA Issues Draft Guidance on LDTs

Inside Precision Medicine

Select article: An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research

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Research article

First published 2016-11

An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research

Khushboo Sharma, Afi Harrington, Sallamar Worrell [...]

Therapeutic Innovation & Regulatory Science

Select article: FDA Issues Guidance for Food,Cosmetic Nanotechnology

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Research article

First published 2012-08

FDA Issues Guidance for Food,Cosmetic Nanotechnology

Biotechnology Law Report

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