Pink Sheet is part 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

Removal Of Outdated FDA Inspection Scheduling Rule Blocked By A Few Individuals

Executive Summary

It may have seemed like a ‘no brainer’ for FDA to immediately remove the outdated two-year inspection requirement for biologics facilities, but the agency will trudge through the full rulemaking process instead owing to what it called ‘significant adverse comment.’ Such a slow turning of bureaucratic gears might not bode well for the Trump administration’s regulatory reforms.

You may also be interested in...



The Quality Lowdown: No Excuses For Homeopathic, CMO, OTC Quality Failures

US FDA assigns blame for quality failures at mostly US-based homeopathic, contract manufacturing and OTC firms, while WHO approves growing manufacturing plant in Kenya.

US FDA Likely Not 'Significant', Could Be Mostly Spared From Trump's Regulation-Slashing Order

But even though executive order that requires regulatory off sets may only have limited application to FDA, limited, experts warn that it still could prove extremely unwieldly to implement.

Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow

FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.

Topics

UsernamePublicRestriction

Register

PS123045

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