Sitemap - 2024 - The FDA Group's Insider Newsletter
How to Write Effective SOPs: A Q&A with Klaus Goodwin, EQSM, LSS BB
Guidance Breakdown: Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies
RA/QA News Roll: Mid April 2024
Strategic Insights from Novartis's Front Lines: Leading Through Transition
Guidance Breakdown: Providing Regulatory Submissions in Electronic Format — IND Safety Reports
RA/QA News Roll: Late March 2024
Real Talk on Remote Leadership with Nick Klingensmith
The Passionate Workforce: How to Create and Maintain Maximum Employee Engagement
The QMSR Explained: The Busy RA/QA Leader's Guide to Compliance Planning
RA/QA News Roll: Mid March 2024
How to Use Interim Consultants and Contractors Effectively in 2024
5 Commonly-Overlooked Strategies for Supplier/Vendor Audits
The FDA Proposes Several Changes to NDA and ANDA Forms
FDA Guidance Breakdown: Key Information and Facilitating Understanding in Informed Consent
RA/QA News Roll: Late February 2024
The FDA is Ramping Up Manufacturing Inspections in India
10 Things You Should Be Doing to Verify Your Testing Labs' Data
10 Questions to Ask Your Testing Lab in Light of FDA's Alert on Fraudulent and Unreliable Data
Audit and FDA Inspection Readiness Best Practices with Divya Gowdar
RA/QA News Roll: Mid February 2024
Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna Dorozinsky
RA/QA News Roll: Late January 2024
🚨 Breaking: The FDA Issues its QMSR Final Rule
FDA Guidance Breakdown: Revising ANDA Labeling Following Revision of the RLD Labeling
FDA Guidance Breakdown: Conducting Remote Regulatory Assessments Questions and Answers
RA/QA News Roll: Mid January 2024
A Unique Look Inside a 510(k) Development and Submission Project
Warning Letter Breakdown: Clinical Investigator Doesn't Adhere to Clinical Study Plan
A Former FDA Digital Health Staffer Graphs the FDA's MDUFA Performance Report Data
FDA Guidance Breakdown: Reformulating Drug Products That Contain Carbomers Manufactured With Benzene