Industry News
Join the MWA Team at these upcoming industry events:
Biotech Week; September 18-21, 2023 – Boston, MA
Attending: Boston Biotech
Master Summit 2023; October 16-20, 2023 – Salt Lake City, UT
Presenting: 2023 Master Summit
FDA Published Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices
FDA published draft guidance on decentralized clinical trials for Drugs, Biological Products, and Devices that provides recommendations on the implementation and design of clinical trials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...
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)...
FDA Released Draft Guidance on the Use of Electronic Systems, Records, and Signatures in Clinical Investigations
FDA released draft guidance for industry use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products, and new animal drugs. The guidance provides recommendations regarding the...
FDA Released Recommendations that Assist in the Development of Monoclonal Antibodies (mAbs) and other Therapeutic Proteins
March 2023, FDA released draft guidance to provide sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of...
New Guidance Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products from FDA
FDA released new guidance considerations for the design and conduct of externally controlled trials for Drug and Biological products. This industry guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical...
FDA Published New Draft Guidance for M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
FDA published new draft guidance for M13A Bioequivalence (BE) for Immediate-Release (IR) Solid Oral Dosage Forms. The guidelines provide recommendations for conducting BE studies during development and post-approval phases for orally administered IR solid oral dosage...
The Impact of Clinical Trial Decentralisation on the Pharma Supply Chain
From Pharmaceutical Technology The world of clinical trials is changing. Technological advancement has made decentralised trials more appealing than ever. Stakeholders must move quickly to ensure they understand the driving forces and are able to adapt effectively....