thought leadership

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.

FDA North America

August 1, 2022

Guidance for Industry: Policy Regarding N-acetyl-L-cysteine

Guidance Document August 2022 The purpose of this guidance is to advise dietary supplement manufacturers, distributors, and other stakeholders of our intent to exercise enforcement discretion with...

MHRA North America

August 1, 2022

UK Paediatric Investigational Plans – what do you need to know?? …and how is it all working in practice??

If a marketing authorisation is planned to be submitted in England, Scotland, and Wales (GB), an MHRA-approved paediatric investigational plan (PIP) is required. Up until January 1, 2021, PIPs were...

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 HIPAA

July 27, 2022

FDA announces the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements

On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to...

FDA North America

July 27, 2022

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...

FDA North America

July 27, 2022

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Final Guidance July 2022 This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred...

ANDA FDA

July 25, 2022

FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...

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...

FDA North America

July 20, 2022

FDA Draft Guidance for Industry, Evaluation of Therapeutic Equivalence

FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...

Prev 1 2 3 4 5

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.