Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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.
Editor's Picks
FDA to Address ‘Narrow’ Labeling of In Vitro Companion Devices for Oncology Drugs
FDA Commissioner Scott Gottlieb noted an increase in new drugs targeting specific molecular markers that drive the growth and spread of cancer.
Gilead’s HIV Drug Approved in China
Descovy received FDA and European Commission marketing approval in 2016.
Regulatory Affairs
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Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript
$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View
Expediting the Generic Drug Approval Process - Webinar Recording/Transcript
$287.00
The FDA announced its Drug Competition Action Plan a year ago. And the agency continues to announce new guidances intended to speed up generic drug approvals. The FDA recently announced a guidance to enhance filing review requirements. Are you — and your new generic — ready for the expedited pathway? View
Chinese Medicine: The Dangers of Deployment - Webinar Recording/Transcript
$287.00
Rosmary Gibson — Senior Advisor at the Hastings Center and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine discusses the real-world impact of Chinese medicine on public health and the scrutiny it’s undergoing. View
REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript
$287.00
REMS has evolved into a powerful enforcement tool. FDAnews has called on Anne K. Walsh, a Washington, D.C. attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. View
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
Complying with Advertising & Promotion Requirements - Webinar Recording/Transcript
$287.00
From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. Take a crash course in dealing with this panoply of enforcers. 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
