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

CMC Regulatory Updates In Brief: Complete Response Tallies And Guidance On Inhalers, Supplements, Liposomes And H2O2

Executive Summary

US FDA attributes 12% of last year's complete responses to manufacturing facility issues. Separately, it proposes a major revision of its 1998 draft guidance on drug quality for metered dose and dry powder inhalers, revises 1999 internal guidance on CMC supplements, and finalizes guidance on CMC considerations for liposomes drafted in 2015, while UK MHRA cautions firms against relying on VHP to sterilize isolator parts.

You may also be interested in...



FDA Accelerates Inspection Process With New Concept Of Operations

'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.

ANDA Sponsors Get Wide-Open Facility Deadline For Priority Review

User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.

INHALATION PRODUCT CMC

...draft guidances from FDA have prompted industry to urge a more flexible regulatory approach in this area. The comments on the new oral/nasal inhalation dosage form guidances represent a consensus industry view of "good practices" for CMC regulatory policy development. Industry is concerned that FDA is taking an overly conservative posture that would hamper technological innovation. FDA, on the other hand, points to the susceptibility of inhalation products to quality problems as justifying a conservative approach. A recent public workshop on inhalation product CMC fuels the debate. (An analysis of inhalation product recall and GMP compliance problems over the past five years is included.)

Topics

UsernamePublicRestriction

Register

SC142962

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