Industry News
Join the MWA and AVS Life Sciences Team at these upcoming industry events:
FDA’s Published Guidance from CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
The FDA published a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality guidance from their Drug Evaluation and Research (CDER) program. This program facilitates submissions by external stakeholders and FDA staff...
FDA Fiscal Year 2022 Report on the State of Pharmaceutical Quality
This report presents analyses that reveal insights about pharmaceutical manufacturers and their products. This information will enable FDA to better prevent and mitigate quality issues that may lead to drug shortages and supply chain vulnerability. Overall, this...
FDA Published Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
FDA published guidance to help sponsors of Investigational New Drug (IND) applications and applicants of Biologic License Applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein. Download the full guidance document...
FDA Paper on Artificial Intelligence in the Manufacture of Medicines
FDA published a discussion paper addressing artificial intelligence (AI) in manufacturing of medical products. The paper details five areas where AI will play a role and areas for consideration and policy development. Please visit ECA Academy for more...
FDA Published Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices
FDA published draft guidance on decentralized clinical trials for Drugs, Biological Products, and Devices that provides recommendations on the implementation and design of clinical trials where some or all of the trial-related activities occur at locations other than...
FDA Published Patient-Focused Drug Development Guidance Document: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making
FDA published the fourth in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used...
Inhalation Sciences: Human and Nonclinical Translational Dose Implications in Respiratory Drug Development Webinar
In this session, Inhalation Sciences discusses the state-of-the-art methods for in vivo exposures for respiratory medicines and reviews case studies demonstrating effective dose translation from non-clinical to clinical investigations. Watch the full webinar...
FDA Publishes Guidance on a Risk-Based Approach to Monitoring Clinical Investigations
FDA publishes guidance information on risk-based approaches to monitoring the conduct of clinical investigations of human drug and biological products, medical devices, and combination products. Clinical investigation monitoring is a quality control tool for...
ECA GMP Equipment Design Guide
The ECA published the guide to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made. Download the guide here.
FDA Issued Guidance to Help Identify Suspect and Illegitimate Product in the U.S. Pharmaceutical Distribution Supply Chain
FDA issued guidance to interpret the terms used in the definition of suspect product set forth in section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21), and the definition of illegitimate product set forth in section 581(8)...