At its meeting of 11-12 September 2017 in Taipei (Chinese Taipei), the PIC/S Committee invited Iran’s Food and Drug Administration (IFDA), the Turkish Medicines and Medical Devices Agency (TMMDA), and Mexico’s Federal Commission for the Protection from Sanitary Risks (COFEPRIS) to join the Scheme from 1 January 2018. Iran / IFDA, Turkey / TMMDA and Mexico / COFEPRIS will become the 50th, 51st and 52nd PIC/S Participating Authorities.
How are OOE and OOT results in the pharmaceutical industry to be recorded and assessed nowadays? To answer this question, the ECA Quality Control Working Group and representatives from authorities and industry compiled a guidance document about the handling of Out-of-Expectation (OOE) and Out-of-Trend (OOT) results.
This 70 page document covers the following issues:
This document also includes seven Annexes; a technical glossary and worked examples to visualize the most important statistical tools and regression methods for a proper setting of stability trend limits.
The FDA published a number of guidances regulating various issues in regards to the new Generic Drug User Fee Act (GDUFA II), which came into force on August 18, 2017. In the following, the content and background of these guidances are summarized (release date in brackets).
Guidance for Industry (Draft) ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA (October 02, 2017)
This guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to either abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) submitted to the Food and Drug Administration under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).
Guidance for Industry (Draft) ANDA Submissions – Refuse-to-Receive Standards: Questions and Answers (October 02, 2017)
This draft guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and certain prior approval supplements (PASs) to ANDAs.
Guidance for Industry (Draft) Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 02, 2017)
This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has submitted an abbreviated new drug application (ANDA) for a complex product to FDA as defined in this guidance.
Guidance for Industry (Draft) ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin (October 02, 2017)
This guideline offers detailed requirements on what data the FDA expects about the quality of a synthetic peptide substance. The impurity profile of the substance is crucial for the successful processing of such an application; the impurities concentration must not be higher than in the original product.
Guidance for Industry (Draft) ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) (October 03, 2017)
This guidance establishes FDA’s expectations for the content, timing, and assessment of sections of the ANDA containing facility information submitted to the Agency not less than 60 days before the priority ANDA submission.
Guidance for Industry (Revision 1) ANDA Submissions – Prior Approval Supplements Under GDUFA (October 04, 2017)
In this guideline, the applicants find information on how amendments are processed by the agency under the GDUFA program. This document is a revision of the original version published in October 2016.
Guidance for Industry (Draft) Determining Whether to Submit an ANDA or a 505(b)(2) Application (October 11, 2017)
This guidance offers applicants a guideline on which procedure to choose in which case based on the different paragraphs in the Food, Drug & Cosmetic Act (FD&C Act).
Guidance for Industry (Draft) Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA (October 13, 2017)
Usually, the FDA’s Office of Generic Drugs sends out a post-complete response letter (CRL) at the end of each review cycle, in which further information is requested due to incomplete data. In order to swiftly clarify any inconsistencies, the applicant may ask for a post-CRL meeting. This guideline offers recommendations for the application, preparation and execution of such a meeting (face-to-face as well as teleconference) and important deadlines as per GDUFA II.
Copyright © 2019 NAGANO SCIENCE CO., LTD. All Rights Reserved