New FDA Guidance for Communication Between IND Sponsors and FDA During Drug Development

The purpose of this draft guidance is to describe best practices and procedures for timely, transparent,and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance describes:1) FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity 2) The scope of appropriate interactions between the review team and the sponsor 3) The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program and 4) General expectations for the timing of FDA response to IND sponsor inquiries, 5) Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development and 6) Expectations for appropriate methods, including the frequency, of such communications. The guidance is available on the FDA website,

More FDA Warning Letters with Data Integrity Issues

FDA inspections and data integrity seems to become a never ending story. This is proven through two new FDA warning letters going to drug and API manufacturers. Examples for cited violations are: Failure to record activities at the time they are performed, e.g., the batch records do not demonstrate that the required review was completed before before releasing the products. Other examples are destruction of original records, failure to prevent unauthorized access or changes to data, no audit trail and no plan to ensure integrity of raw data. The warning letters can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 300 and 299).  To learn everything about FDA expectations for raw data, attend the Labcompliance audio seminar  "Ensuring Data Integrity for FDA/EU Compliance"

FDA released the final Guidance on Formal Meetings with Biosimilar  Product Sponsors 

This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. This guidance finalizes the draft guidance issued on April 1, 2013. The guidance is available on the FDA website.

PIC/S Answers Frequently Asked Questions

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) is getting more and more powerful. There are currently 46 Participating Authorities in PIC/S  and many more have applied to become a  member. We at Labcompliance inform our NEWS readers about ongoing PIC/S activities. We also get many questions about the regulatory impact of PIC/S. We cannot answers all questions but in this case refer to the PIC/S questions and answers web site. Examples questions are: Does PIC/S issue GMP Certificates? Do PIC/S Members recognize GMP certificates from other PIC/S Members? Does PIC/S perform inspections and certify individual company plants? Are PIC/S training activities open to industry?

Seven New Class-Room Trainings with Dr. Ludwig Huber in Zurich, San Francisco, Mumbai, Hong Kong and Sydney

Dr. Ludwig Huber will conduct seven 2-day public seminar seminars on Analytical Instrument Qualification and System validation, on Computer System Validation and Part 11 Compliance and on Validation and Transfer of Analytical Methods. The seminars are organized by Complianceonline and Globalcompliancepannel. They will be delivered as workshops and interactive discussions. Attendees will receive 20+ good practice guides such as SOPs, validation examples and templates for easy implementation.

Here are the dates and locations

• Analytical Instrument Qualification and System Validation,
  February 16/17, San Francisco, CA
• Validation, Verification and Transfer of Analytical Methods
  February 18/19, 2016 San Francisco, CA
• Validation, Verification and Transfer of Analytical Methods
  March 8/9, Zurich Switzerland
• Validation and Part 11 Compliance of Computer Systems and Data:,
  March 17/18, Zurich, Switzerland
• Validation and Part 11 Compliance of Computer Systems and Data:,
  April 21/22, Sydney, Australia
• Validation and Part 11 Compliance of Computer Systems and Data:,
  April 25/26, Hong Kong
• Validation and Part 11 Compliance of Computer Systems and Data:,
  April 28/29, Mumbai, India