FDA Draft Guidances: ANDA Submissions – Refuse to Receive for Lack of Proper Justification of Impurity Limits & Refuse-to-Receive Standards

14.11.06FDA has released two draft guidance documents on refuse to receive ANDA submissions. The purpose of the guidances are to help applicants prepare “ANDAs and PASs to ANDAs for which the applicant is seeking Continue reading

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Health Canada Publishes New Drug Establishment Licence (DEL) Application Form and Instructions (FRM-0033)

FRM-0033On October 23, 2014, Health Canada released a new Drug Establishment Licence (DEL) Application Form (FRM-033) with instructions. This form supersedes the Continue reading

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Ebola: A Clinical Trial and Ethics Perspective

The world and the African continent in particular are currently experiencing the worst Ebola virus disease (EVD) outbreak in modern history. With more than two thousand deaths estimated due to the Continue reading

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EMA releases revised guidance on EU Periodic-Safety-Update-Report Single Assessment for Nationally Authorised Medicines

EMA Revised Guidance on EU Periodic-Safety-Update-Report Single Assessment for Nationally Authorised MedicinesThe revised procedural guidance European Medicines Agency Post-Authorisation Procedural Advice for Users of the Centralised Procedure is intended “to ensure that Continue reading

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Health Canada Publishes Guidance Document on the Application for a Certificate of a Pharmaceutical Product (CPP)

Health Canada Guidance: Application for a Certificate of a Pharmaceutical ProductA Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of Continue reading

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EMA to model new International Generic Drug Regulatory Pilot Project (IGDRP) after EU Decentralized Drug Submission Procedure

The International Generic Drug Regulators Pilot (IGDRP) was created in 2012 to promote collaboration and convergence in generic drug regulatory programs in order to Continue reading

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Health Canada Releases Revised Draft Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions

Health Canada: Draft Guidance on Reconsideration of Decisions Issued for Human Drug Submissions

This revised Draft Guidance on Reconsideration of Decisions Issued for Human Drug Submissions is intended to describe the appropriate process to address submission-related disputes and Continue reading

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Regxia’s clients speak, “Regxia has our heartfelt appreciation…to develop this filing…in the shortest time-frame possible…”

August 7, 2014. Regxia’s clients speak: “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our Continue reading

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FDA issues revised draft guidance for providing Regulatory Submission in e-CTD format

FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications adn Related Submissions Using eCTD SpecificationsOn July 25, 2014 FDA issued revised draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.”   This revised draft guidance Continue reading

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Health Canada Draft Guidance Document: Drug Submissions Relying on Third-Party Data [Literature and Market Experience]

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/consultation/drug-medic/srtd_draft_guid_pfdt_ebauch_ld-eng.pdfHealth Canada has released a consultation document regarding drug submissions relying on third-party data (literature and market experience). The guidance applies to Continue reading

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