Simplifying Global Compliance
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GMP Inspection Preparation Checklist: A Tool for Internal Auditing
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Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Senators Question Digital Health Pre-Cert Program
The agency “should be focused on ensuring it has the tools and capacity to guarantee that software products that perform medical device functions are safe and effective and to hold companies that skirt the rules accountable,” the letter states.
Pfizer Gets FDA Nod for Breast Cancer Drug
The agency based its approval on the results of a 431-patient trial.
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Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript
$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View
FDA’s New Biosimilars Plan - Webinar Recording/Transcript
$287.00
To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market. FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know about the FDA’s Biosimilars Action Plan — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. View
Quality Metrics Redux - Webinar Recording/Transcript
$287.00
The FDA began a year-long voluntary site visit program in August to learn what types of metrics drugmakers collect — and which are the best indicators of quality success or failure. It intends to use quality metrics to support its risk-based inspection planning with mandatory participation. View
The CDER Reorganization: What It Means for Drugmakers - Webinar Recording/Transcript
$287.00
Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research. View
Pharmacy Compounding Regulation - Webinar Recording/Transcript
$287.00
What can you expect from the FDA’s 2018 Compounding Priorities Plan? View
GDP Audit Checklist: Meeting Global Transport and Storage Requirements
$230.00
GDP Audit Checklist: Meeting Global Transport and Storage Requirements is written by Simone Ferrante, Head of Quality & Regulatory Affairs for Grieshaber Logistics Group AG, Bad Säckingen. She implemented the company’s GDP/GMP-compliant quality management system. View
What CDER Can and Can’t Do: An Inside Look from an Agency Official - Webinar Recording/Transcript
$287.00
CDER, the FDA’s drug-approval arm, pays attention to patient and caregiver input … and so should you. Dr. Khatri shows you what CDER has done, what it wishes to do, and what law and regulation prevent it from doing. View
Corporate Compliance & Liability - Webinar Recording/Transcript
$287.00
It’s easy to lose sight of the big picture. But you do so at your peril. FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble. View
Commissioner Gottlieb’s FDA: His First Year and a Look Ahead - Webinar Recording/Transcript
$287.00
What we know about the Gottlieb FDA: That lots is getting done. What we need to know: What will he do next? View
Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript
$287.00
The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well. View
eCTD Submissions — What You Need to Know to Comply with FDA Requirements - Webinar Recording/Transcript
$287.00
Drug and biologics makers have dodged a bullet — twice — on electronic filings (eCTD) of INDs, DMFs, ANDAs, NDA, and BLAs. But the new deadline — May 5, 2019 — will be here before you know it. View
Investigations Operations Manual 2018
$377.00
Don’t wait for FDA investigators to tell you what their new focus is when they’re already at your facility. Get a heads up with Investigations Operations Manual 2018. View