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Research article

First published 2022-3

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

Chandan Saini, Ashish Miglani, Pankaj Musyuni [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2021-12

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

Lovely Joylein, Bishop Adhikari, Megha Chellath Kottayi [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2019

Postmarketing Safety of Biosimilars: Current Status,Challenges,and Opportunities in the Spontaneous Reporting System

Abhishek Singh, Muthusamy Kalaivani, Sushma Srivastava [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-1

Photocure ASA v. Kappos et al and Actavis Elizabeth LLC v. USFDA : The Meaning of ‘Active Ingredient’ in the Hatch–Waxman Act

Frederick H. Rein, Joseph B. Crystal

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Free access

Research article

First published 2017-9

The Cosmetic Ingredient Review Program—Expert Safety Assessments of Cosmetic Ingredients in an Open Forum

Ivan J. Boyer, Wilma F. Bergfeld, Bart Heldreth [...]

International Journal of Toxicology

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Review article

First published 2023-3

A retrospective analysis on the product recall due to solvent and mineral residue issues

Salman Ahmed, Pankaj Musyuni, Geeta Aggarwal

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Open access

Research article

First published 2018

Low Potency of Indian Dust Mite Allergen Skin Prick Test Extracts Compared to FDA-Approved Extracts: A Double-Blinded Randomized Control Trial

Devasahayam J. Christopher, Narmada Ashok, Aruna Ravivarma [...]

Therapeutic Advances in Allergy and Rhinology

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Research article

First published 2025-10

Drug-Associated Tendinopathies and Ligament Disorders: Results from a Retrospective Pharmacovigilance Study Using Disproportionality Analysis

Kannan Sridharan

Hospital Pharmacy

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Research article

First published 2025-12

Drug-Associated Alcohol Intolerance: A Real-World Disproportionality Analysis Study

Kannan Sridharan, Gowri Sivaramakrishnan

Hospital Pharmacy

Open access

Research article

First published 2017-12

The Evaluation of Total Mercury and Arsenic in Skin Bleaching Creams Commonly used in Trinidad and Tobago and their Potential Risk to the People of the Caribbean

Terry Mohammed, Elisabeth Mohammed, Shermel Bascombe

Journal of Public Health Research

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