Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Combination Product Oversight Will Be Partly Affected By Drug GMP Initiative

This article was originally published in The Gray Sheet

Executive Summary

FDA's initiative to enhance pharmaceutical good manufacturing practices will apply to combination products that have biological drug or drug components
Advertisement

Related Content

CDRH 483s Will Include Language Developed Under GMP Initiative
CDRH 483s Will Include Language Developed Under GMP Initiative
Part 11 Risk-Based Approach To Be Communicated To FDA Field Staff
Part 11 Risk-Based Approach To Be Communicated To FDA Field Staff
Part 11 draft guidance withdrawn
Part 11 draft guidance withdrawn
MDUFMA Addresses In Vitro Diagnostics, Combination Product Regulation
Primary Mode of Action Is A Primary Focus Of Combo Products Hearing
Primary Mode of Action Is A Primary Focus Of Combo Products Hearing
Hatch Takes Aim At Kennedy’s Commissioner Criteria, Supports Crawford
Advertisement
UsernamePublicRestriction

Register

MT017048

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel