Submissions and Approvals

ARTICLES

PRODUCTS

Observational Research - Webinar CD/Transcript

$287.00
The 21st Century Cures Act promises to usher in a new era of drug development by dramatically lowering the cost of clinical trials while speeding the path to market. Noted researcher Jeff Trotter shows you how to take full advantage of the Cures Act and start reducing drug trial costs today. View

Brexit and Life Sciences Companies - Webinar CD/Transcript

$287.00
Your international drug and device business is at a crossroads known as ‘Brexit’ — the imminent departure of the United Kingdom (U.K.) from the European Union (EU). FDAnews has invited global drug-and-device expert Michael Burke Esq. to share his crystal ball. As law his firm’s in-house expert on drugs and devices as well as a specialist in cross-border international trade, Mr. Burke is uniquely qualified. View

Guide to FDA and EU Medical Device Regulations, 2017 Edition

$397.00
NEW for 2017 — You’ll get the full text (more than 1,000 pages) of the European Union’s newly revised regulations for medical devices and in vitro diagnostic devices. View

The FDA Under a New Commissioner - Webinar CD/Transcript

$287.00
Likely new FDA Commissioner Scott Gottlieb is an old agency hand thrust into a new role. Will he toe the Trump line ... or show independence? Is his past a guide ... or will he strike out in new directions? Will he ease new drug and device approvals ... or toughen them? Increase inspections ... or ease off? More 483s and warning letters ... or fewer? View

Nine-Volume Title 21 CFR Set 2017

$585.00
The federal government has compiled the new 2017 CFR volumes.






View

Seven Steps to Successful Medical Device Reimbursement

$397.00
Order Seven Steps to Successful Medical Device Reimbursement for an overview of the regulatory and reimbursement processes and how they fit together. View

Dealing with Chinese Medical Device Regulatory Authorities - Webinar CD/Transcript

$287.00
To American eyes, the Chinese regulatory system is ... well, a Chinese puzzle. You can’t hope to get a registration approved without a knowledgeable and trustworthy local guide. Face it: You need expert help. And we’ve got just the expert to help you. View

Medical Device Clinical Evaluation Reports - Webinar CD/Transcript

$287.00
Michelle McDonough — Associate Director, Regulatory and Clinical Affairs, MCRA — discusses the requirements for CERs and their place in supporting new device certification and maintaining certification. She will cover best practices for completing CERs, complying with regulations including the MEDDEV 27/1 Rev 4 guidance. View

Devicemaker’s Guide to the 21st Century Cures Act: Changing the Face of Medical Device Regulation

$397.00
Devicemaker’s Guide to the 21st Century Cures Act tells you what to expect in the coming months, which new provisions are likely to cause trouble and how to get out in front of the changes. View

Navigating China’s Medical Device Regulations

$397.00
Navigating China’s Medical Device Regulations brings you up to date, explaining how the Chinese system and culture work, what the regulatory changes are, how to react to new requirements and what may come in the future. View

FDA’s Guidance on Postmarket Management of Cybersecurity in Medical Devices - Webinar CD/Transcript

$287.00
How can you protect your medical devices from ever-changing cybersecurity threats? Join Nick Sikorski and Robert Mai — both of Deloitte & Touche LLP – Cyber Risk Services — for a discussion on the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. View

Combination Products and Cross-Center Reviews - Webinar CD/Transcript

$287.00
Mapping out a regulatory pathway for drug/device/biologic combination products remains one of the most difficult regulatory challenges for life sciences innovators. Join David M. Fox — Partner, Hogan Lovells — for a close look at the FDA’s new authority governing combination products and several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View