Industry News
Join the MWA and AVS Life Sciences Team at these upcoming industry events:
FDA Released Draft Guidance on the Use of Electronic Systems, Records, and Signatures in Clinical Investigations
FDA released draft guidance for industry use of electronic systems, electronic records, and electronic signatures in clinical investigations of medical products, foods, tobacco products,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March 2023, FDA released draft guidance to provide sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral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FDA Published New Draft Guidance for M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
FDA published new draft guidance for M13A Bioequivalence (BE) for Immediate-Release (IR) Solid Oral Dosage Forms.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....
FDA Publishes Lists of Planned Medical Device Guidances for Fiscal Year 2023
From ECA Academy FDA's Center for Devices and Radiological Health (CDRH) published a list of new guidances planned for fiscal year 2023 (1 October 2022 - 30 September 2023). The CDRH divides the list into an "A" and a "B" priority. The documents listed under "A"...
ICH Q9(R1) Guideline reaches Step 4 of the ICH Process
The ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 of the ICH Process. This Guideline is intended to provide guidance on the principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical...
MWA welcomes Michelle Hoover as Account Manager
MWA is pleased to announce that Michelle Hoover has joined our team as Account Manager. Michelle is an experienced client services leader in the pharmaceutical industry in areas of Contract Manufacturing, Supply Chain, and Development. She has over ten years of...
New REMS Guidance Documents from FDA
FDA has released final guidance that provides updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including a biological drug product. A REMS document, which is part of a REMS...
FDA proposes changes to Investigational New Drug Application Annual Reporting
The Food and Drug Administration (FDA) is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed annual FDA DSUR is...