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EMA Europe

June 20, 2022

Validation checklist for initial marketing authorisation applications - biologicals other than immunologicals (applicable to submissions under Regulation (EU) 2019/6)

JUNE 2022 EMA/278419/2022-Rev.1 This validation checklist is used by the Agency to validate initial marketing authorization applications for pharmaceuticals and applicants should use it as a means to...

FDA North America

June 17, 2022

Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions

Guidance Document Guidance for Industry and Food and Drug Administration Staff JUNE 2022 This guidance document provides FDA's recommendations on the information, technical performance assessment,...

FDA North America

June 16, 2022

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies

Guidance Document Draft Guidance for Industry June 2022 This guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation...

FDA North America

June 15, 2022

Q9(R1) Quality Risk Management

Guidance Document June 2022 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any...

FDA North America

June 7, 2022

Electromagnetic Compatibility (EMC) of Medical Devices

Guidance Document June 2022 This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the...

EMA MAH

June 2, 2022

EMA: Procedural advice for vaccine platform technology master 5 file (vPTMF) certification (DRAFT)

This document is intended to provide advice to marketing authorisation (MA) applicants and marketing authorisation holders (MAHs) on issues associated with the submission, evaluation, certification...

CDER FDA

May 31, 2022

Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues

Guidance Document Center for Drug Evaluation and Research This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to...

FDA North America

May 25, 2022

Importation of Prescription Drugs Final Rule Questions and Answers

Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada Guidance for Industry Today, FDA issued a Small Entity Compliance Guide to help small businesses comply...

EMA MAH

May 24, 2022

EMA post-authorisation procedural advice for users of the centralised procedure

This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on...

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