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 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...
FDA Warning Letters of the Fiscal Year 2022: the “Top Ten” GMP Deficiencies
From ECA Academy The systematic analysis of the GMP deficiencies recorded during an inspection reflects, on the one hand, what FDA inspectors focus on and, on the other hand, provides clues for preparing for an upcoming inspection by the FDA. In the fiscal year 2022...
ECA Good Practice Guide for Effective Qualification and Validation 2.0
The ECA Validation Group has released an updated version of the Good Practice Guide for effective qualification and validation. Download the guide here.
FDA Launches Pilot Program to Support Rare Disease Drug Development
FDA is establishing a Rare Disease Endpoint Advancement (RDEA) Pilot Program to support novel efficacy endpoint development for drugs that treat rare diseases. The RDEA Pilot Program fulfills a commitment under PDUFA VII. The RDEA Pilot Program is designed to: Seek to...
MWA to Present at the Masters Summit in Salt Lake City
MWA team members Sumaiya Reza, VP of Client Services, and Lisa Helmonds, VP of Quality and Operations, will be attending the Masters Summit Conference October 24-28, 2022 in Salt Lake City, UT. Don’t miss their breakout session October 25th on Business Leadership –...
The Criticality of Supplier Management and Keys to Improvement
Posted September 29, 2022 on GXP Lifeline/MasterControl. This article by MWA team members Lisa Helmonds and Myrna Russell will help you learn how to simplify and strengthen your supplier management program. Read more here.