Submissions and Approvals

ARTICLES

CBO Scores FDA User Fee Bill

The FDA needs to receive $1.2 billion between 2018 and 2022 to make possible the changes presented in the user fee reauthorization bill currently before Congress. Read More

PRODUCTS

FDA’s Big 5 Challenges - Webinar CD/Transcript

$287.00
The FDA likely will break new ground this year, posing extraordinary regulatory challenges to Rx, food and tobacco interests. Botox. Cannabis. Opioids. Tobacco intended use. State right-to-try initiatives. How will the FDA tackle these hot potatoes? View

Spreadsheet Validation 2017 - Webinar CD/Transcript

$287.00
What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he highlights potential pitfalls and defines innovative validation approaches ... ask why he does this instead of that ... and get feedback? View

Drugmaker’s Guide to ASTM E2500: Best Practices for Increasing Process Efficiency and…

$397.00
Drugmaker’s Guide to ASTM E2500 explains the principles of ASTM E2500, uses case studies to show how to best implement it and shows how to use the standard to fulfill FDA expectations. View

Impact: FDA User Fees, Drug Competition and Pricing - Webinar CD/Transcript

$287.00
User fees affect drug competition at every level. And user fees are set to rise. Top-level meetings are under way at the FDA, the White House and in Congress. Policy is being hammered out amid great uncertainty under a new FDA administrator, Scott Gottlieb and a new White House that boasts no special background in drug policy or regulation. View

Drug or Device? How the 21st Century Cures Act Impacts Combination Products

$397.00
Drug or Device? How the 21st Century Cures Act Impacts Combination Products takes a close look at the FDA’s new authority governing combination products, as well as several new provisions under the 21st Century Cures Act that could usher in a new era of interdisciplinary product reviews at the FDA. View

Best Practices in Food Process Labeling & Regulation - Webinar CD/Transcript

$287.00
A strong health claim can send your products flying off the shelves. But go too far and you risk sanctions from the FDA, FTC and USDA to state and local health departments, not to mention the ire of consumer groups and their well-paid lawyers. Here’s how to stay on the safe side of the line. View

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

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.






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Drugmaker’s Guide to the 21st Century Cures Act: Changing the Face of Pharmaceutical and Biologics Regulation

$397.00
The Drugmaker’s Guide to the 21st Century Cures Act e-book 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

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