Industry News
Join the MWA and AVS Life Sciences Team at these upcoming industry events:
ISPE 31st Annual Vendor Night Exhibit Show, March 14, 2024, at Oracle Park in San Francisco, CA
Pharma MES USA, March 20-22, 2024 in San Diego, CA
All Star Project-Becoming All Stars 2024, March 23, 2024 in Hayward, CA
American Biomanufacturing Summit, April 10-11, 2024 in San Francisco, CA
ISPE Bay Area Chapter: Bayer Facilities Tour, April 11, 2024 in Berkeley, CA
Diversity Alliance for Science-East Coast, April 30-May 2, 2024 in Newar NJ
32nd Annual ISPE DVC Symposium and Exhibition, June 18, 2024 in Philadelphia, PA
FDA Guidance Document Regarding Quality Considerations for Ophthalmic Drug Products
FDA published draft guidance providing information regarding quality considerations for ophthalmic drug products consistent with the current good manufacturing practice (CGMP) requirements. This guidance revises the draft guidance issued in October 2023. This revision...
FDA Launches New Webpage for Searching Pharmaceutical Quality Documents
FDA launched a new search function on FDA’s Office of Pharmaceutical Quality webpage to improve access to drug quality resources and web content. The new search page scans existing FDA guidance documents, manuals of policies and procedures (MAAPs), and compliance...
FDA Draft Guidance on Expectations for the reviews of 510(k) Submissions and EUA Requests
This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by...
Automation & Validation Solutions, LLC Acquires MWA Consulting, Inc.
We are thrilled to share the news that MWA Consulting, Inc., a leader in GxP quality and regulatory compliance consulting for the life sciences industry, has been acquired by Automation & Validation Solutions, LLC (AVS), a global provider of quality management,...
FDA Draft Guidance on the Agency’s Continued Use of Remote Evaluations
FDA is issuing this draft guidance to inform industry about the agency’s continued use of remote evaluations as an approach for evaluating drug facilities, as appropriate. This guidance articulates the specific conditions that both the facility and FDA should meet...
FDA Published Draft Guidance on Electronic Submission Template for Medical Device De Novo Requests
The FDA issued draft guidance to introduce De Novo request submitters to the current resources and associated content developed and made available to support medical device De Novo electronic submissions to the Center for Devices and Radiological Health (CDRH) and...
CDER’s Quality Management Maturity Program: Practice Areas and Prototype Assessment Protocol Development
FDA’s Center for Drug Evaluation and Research (CDER) is establishing a program to promote quality management maturity (QMM) at drug manufacturing establishments. The QMM program aims to encourage drug manufacturers to implement quality management practices that go...
FDA’s Informed Consent Regulations for Clinical Investigations
FDA published guidance to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This document provides general guidance on FDA’s regulatory requirements for...
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...