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.

Menu

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
Menu
My View
  • Edit
  • Add your favourite topics for quick access
Meet the Team
Ask the Analyst
Partnered Content
PDF Library
RSS Feeds
Subscribe
FAQs
Advertising
Report Store
UsernamePublicRestriction
Tags:
Quality Compliance Drug Approval Standards

Can We Talk? US FDA Remote Records Review Missteps Worry Industry

  • Analysis

Executive Summary

Alkermes CRL is just the latest fallout from black-hole process.

You may also be interested in...



US FDA Reaffirms Commitment To Resuming Domestic Inspections As Industry Frustration Grows

Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.

Blame It On COVID: Alkermes CRL Tied To Remote Site Inspections

Alkermes’ combo pill for schizophrenia and bipolar disorder received an FDA complete response due to manufacturing questions that a physical site review might have resolved.

US FDA Assesses Over 500 Biopharma Plants Remotely Via Records Review; Refines Process

Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.

Table

View full table

Topics

Related Companies

Tags:
Quality Compliance Drug Approval Standards
UsernamePublicRestriction

Register

OM006922

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

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