Regulatory Blog

The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...

As part of its updated guidelines on testimonials and endorsements in advertising, the Therapeutic Goods Administration (TGA) updated its...

The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...

The USFDA recently released draft guidance intended to help stakeholders develop, maintain, and implement risk management plans (RMPs) to...

FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication...

The Drug Regulatory Authority of Pakistan (DRAP) published the draft of this guidance document on its website on 8th April 2022 inviting...

The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections authorizing FDA to assess and collect user fees for a five-year...

USFDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production"....

Yesterday the European Medicines Agency released updated IRIS guidance on "How to create and submit scientific applications, for industry...

On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...

On 10-May-2022 the Saudi Food & Drug Authority (SFDA) released updated guidance on "Guidelines for Variation Requirements". These...

Earlier on 9-May-2022, FDA announced that a draft guidance document was available to assist the industry regarding the Benefit-Risk...

The International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Guide (MDCG) Working Group Proposed document...

South African Health Products Regulatory Authority updated its guidance on Pharmacovigilance Inspections for Human Medicinal Products....

Clinical trials contribute significantly to advances in medical treatment. A new EU Clinical Trial Regulation (Regulation No 536/2014,...

The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s...

Pakistan's Drug Regulatory Authority (DRAP) has finalized its guidelines for imports and exports of therapeutic goods. This document...