IPQ Inside the global regulatory dialogue

Your Search Results

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.

FDA Preapproval Inspections Enhanced by New Guidance, Reviewer Participation

Increased reviewer engagement with investigators is impacting the preapproval inspection (PAI) process and helping FDA address the growing complexity of products and processes it faces in reviewing new drug applications (NDAs) and their supplements (sNDAs)....

Facility Listing Errors and Missing Development Data Draw Withhold Recommendations From FDA’s NJ District

Facility listing errors on the application and a lack of availability of development data source documents during pre-approval inspections are causing the New Jersey District to recommend withholding drug approvals, its investigations branch director Myriam Sosa told DIA’s June Annual Meeting....

FDA Adjusts Its Pre-approval Inspection Guide To Reflect ICH Q8-10 Paradigm

FDA has updated its pre-approval inspection (PAI) compliance program guidance (CPG 7346.832) to better reflect the agency’s 21st century quality initiative and the new ICH Q8-10/QbD regulatory paradigm….

Subscription Benefits

SUBSCRIBE TODAY and get 24/7 access to the IPQ family of publications:

● “In the News” — breaking stories on our website

● “News Alerts” — sent via email

● “Monthly Updates” — the key CMC and GMP developments in the US, Europe and internationally

● “Special Reports” — in-depth analysis of specific, emerging issues of regulator/industry concern

Documents and Archives — Live links to all the documents referenced in our stories and full access to IPQ’s valuable archive library



CLICK HERE  for the IPQ Monthly Update – May 2021 in Review

IPQ takes its readers from:

● the headlines to the forces driving them

● regulations and policies to their underlying intent

● the pieces of the puzzle to their interconnection

● requirements to implementation pathways

● random data to critical trends

● the sidelines to helping shape the outcome

● compliance problems to proactive quality tools

● information to intelligence


©2021 IPQ Publications