Research and Development

ARTICLES

FDA Allows In Vitro Studies to Demonstrate Naloxone Bioequivalence

For the development of generic versions of naloxone, an emergency nasal spray treatment for opioid overdoses, the FDA said it will allow sponsors to demonstrate bioequivalence using solely in vitro performance tests — as long as the generic is qualitatively the same as the reference product. Read More

SUBSCRIPTIONS

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

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

Clinical Research Manual

$380.00
Clinical Research Manual brings together guidance on everything from pharmacokinetics and study design, to recruitment, monitoring, statistics… all the problem compliance areas you need to stay on top of to conduct clinical trials that will stand up to regulatory scrutiny. View

Industry Trends and Best Practices for the Cleanroom Environment - Webinar CD/Transcript

$287.00
Cleanrooms are complicated. Product selection, rotating disinfectants, applying disinfectants and controlling bioburdens and residues are all part of the job. But what is the best way to handle it all? View

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

Five Case Studies Using the E2500 Approach to Validate Equipment, … - Webinar CD/Transcript

$287.00
The E2500 approach streamlines design qualification by focusing on design and verification of critical aspects of a manufacturing system that affect product quality and patient safety. Implementation is not easy, but worthwhile. Once implemented E2500 can effectively reduce the testing, staffing, costs and time associated with the design-qualification phase of a system’s lifecycle. View

The 21st Century Cures Act & Regenerative Medicine - Webinar CD/Transcript

$287.00
The biologics license application (BLA) is perhaps the most burdensome and lengthy premarket review process that the FDA imposes. To address that, Congress created the Regenerative Advanced Therapy (RAT) designation. View

Clinical Trial Compliance Guide: FDA Requirements

$397.00
The FDA has issued more than 100 guidance documents relating to clinical trials covering topics from the Animal Rule to validating software used in studies. If you had to pull all of them together yourself — and get the right version — it would take you hours. View

The 21st Century Cures Act — Impact on Pharmaceuticals - Webinar CD/Transcript

$287.00
What do you need to know about the 21st Century Cures Act in order to thrive this year? Join legal expert Jim O’Reilly for a discussion on the biggest change in the daily activities of the drug regulatory community in five decades. View