Subscribe
  
IPQ Inside the global regulatory dialogue

Your Search Results

IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

Clarifying Questions Upfront is Key in Process Validation, US and EU PV Principles in Alignment, CDER’s McNally Stresses 

FDA is advising industry to ensure that their process validation teams clearly articulate and document the questions they are seeking to answer up front, prior to collecting data or executing process qualification (PQ).

Phased Implementation, Reporting Burden Among Industry Focal Points in Initial Feedback on FDA’s Quality Metrics Draft Guidance

Phased implementation, reporting burden, and the nuances of site versus product reporting were among the focal points of the comments by the various associations appearing at the public meeting held by FDA on August 24 to capture industry’s initial feedback on the agency’s quality metrics draft guidance.

Relationship with Excipient Providers Drawing Increasing Pharma Attention, BMS Exec Stresses; IPEC Urges Regulatory Pathway for New Excipients in GDUFA/PDUFA Comments

An important component in the ability of pharmaceutical innovators to bring their new products to market in the eclipsed timelines in which they need to function will be their relationship with excipient providers, a top manufacturing executive from Bristol-Myers Squibb (BMS) stressed to participants at the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas)/ExcipientFest conference […]

IPQ Monthly Update, June 2015

In focus are: ● FDA’s CDER on the role of the control strategy in application approval recommendations and the challenges reviewers face in piecing the story together ● the key role a novel excipient played in the development of a new insulin inhalation product and the broader implications of the experience, and ● ICH’s effort to address the pressing questions on API CMC and GMP through Q&As on Q7 and Q11....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

International Counterfeit Medicines Effort

In Mid-June, FDA, in partnership with international regulatory and law enforcement agencies, took action against more than 1,050 websites that illegally sell potentially dangerous, unapproved prescription medicines and medical devices to consumers. These actions include the issuance of regulatory warnings to the operators of offending websites and seizure of illegal medicines and medical devices worldwide. […]

MHRA Business Plan

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 2015/16 business plan was published at the end of June. Key strategic activities for 2015-16 include: ● bringing innovation and new products speedily and safely to patients ● strengthening surveillance ● ensuring safe medicines and devices and secure supply in globalized industries, and ● achieving a […]

FDA Trip to China

In an FDA blog post, Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg, Center for Drug Evaluation and Research (CDER) Deputy Director Richard Moscicki, and Office of Regulatory Affairs (ORA) Pharmaceutical Quality Program Acting Director Alonza Cruse report on a recent trip they made to China. During the trip, the senior FDA officials […]

FDA Guidance on Cell-Based Products for Animal Use

FDA has released a guidance on “Cell-Based Products for Animal Use.” It describes the current thinking at the Center for Veterinary Medicine (CVM) on the development, manufacturing, and marketing of cell-based products for animal use that meet the definition of a new animal drug.
Pages: 1 2 3 4 5 6 7 8 9 10 ...48 49 50 Next

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 – June 2020 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

.

©2020 IPQ Publications