Latest Regulatory Updates

This FDA webpage lists non-compliance letters issued under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act, detailing instances where facilities failed to comply with requirements related to applications for drug products.

This FDA webpage provides a comprehensive list of vaccines currently licensed for use in the United States, including their manufacturers and indications.

This FDA webpage provides information and resources related to Registered Outsourcing Facilities (ROFs) under the Compounding Quality Act, outlining requirements for registration, inspections, and compliance with current Good Manufacturing Practice (CGMP) regulations.

The FDA has approved several competitive generic therapies, demonstrating the agency's ongoing efforts to provide patients with more affordable access to essential medicines.

The FDA approved IXCHIQ (ixazomib-exxe), a biosimilar of Velcade, for the treatment of multiple myeloma.

This document provides a roster of members for the Vaccines and Related Biological Products Advisory Committee, outlining their expertise and roles in advising the FDA on biological product-related matters.

The European Medicines Agency (EMA) has released a validation checklist to assist marketing authorization holders in preparing Type II (non-clinical) variations and ensure completeness for efficient assessment.

The MHRA is launching work-sharing initiatives to improve efficiency and reduce duplication in the assessment of new active substances and biosimilars, collaborating with other regulatory agencies like EMA and Health Canada.

This FDA Grand Rounds presentation will discuss the postmarket regulatory oversight of cosmetic products, covering aspects such as responsible parties, regulated activities, timing, rationale, and methods.

This document outlines exemptions from Investigational New Drug (IND) application requirements, detailing specific research activities and biological products that are not subject to these regulations.

This guidance document from the FDA outlines the responsibilities of investigators involved in submitting and conducting clinical trials under an Investigational New Drug (IND) application.

This FDA guidance document provides an overview of the requirements for reporting information related to Investigational New Drug (IND) applications, outlining the types of data and submissions expected from sponsors.

This guidance document from the FDA outlines procedures and expectations for interactions between sponsors and the agency during the Investigational New Drug (IND) application review process.

This FDA overview document details the Investigational New Drug (IND) application process required for initiating clinical investigations of new drugs and biologics in the United States.

This guidance from the FDA clarifies reporting requirements for protocol amendments submitted as part of Investigational New Drug (IND) applications, outlining what information must be included and how it should be reported.

This FDA announcement provides a list of addresses to which Investigational New Drug (IND) applications should be submitted, clarifying the routing for these regulatory submissions.

This concept paper outlines the EMA's plan to develop a reflection paper exploring the appropriate use of Bayesian methods within clinical development, aiming to provide guidance for pharmaceutical companies.

This concept paper outlines planned revisions to the EMA guideline on clinical evaluation of diagnostic agents and its appendix 1 concerning imaging agents, seeking feedback from stakeholders on proposed changes.

This publication details the MHRA's decisions regarding registered medicinal products designated as orphan medicines, outlining their status and associated regulatory considerations.