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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

ANDA FDA

July 29, 2022

FDA announces guidance for industry titled Changes to Disposable Manufacturing Materials: Questions and Answers

Today, FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited...

FDA North America

July 21, 2022

Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding”

Draft Guidance July 2022 This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the...

ANDA FDA

June 27, 2022

How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”

On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...

FDA NDA

May 18, 2022

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...

FDA North America

May 9, 2022

FDA announces draft guidance on Benefit-Risk Considerations for Product Quality Assessments

Today, FDA announced the availability of a draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This guidance describes the benefit-risk principles applied by FDA...

ANDA FDA

April 27, 2022

Providing Submissions in Electronic Format — Postmarketing Safety Reports

GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...

CMC NDA

February 15, 2022

CMC Regulatory Dossier Compliance: A GMP Requirement

Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...

ANDA NDA

February 5, 2020

The Importance of the eCTD Structure for FDA Approval

The Importance of the eCTD To harmonize the process of regulatory reviews for global drug development, a unified structure was developed and implemented for electronic Common Technical Document...

ANDA NDA

February 27, 2018

Drug Development: The Key to Success from Concept to Commercialization

Drug Development: The Key to Success from Concept to Commercialization: Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?”....

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