Submissions and Approvals

ARTICLES

EMA Calls for Details, Narratives in Marketing Applications

Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More

PRODUCTS

Implementing Elemental Impurities Testing - Webinar CD/Transcript

$287.00
A little more than a year ago, a paradigm shift occurred in testing for elemental impurities. The then-new ICH Q3D guideline established tough new expectations for new drugs. View

Biosimilars Regulation: The Importance of Interchangeability - Webinar CD/Transcript

$287.00
The biosimilars industry is at a crossroads known as interchangeability. Drug and biologics firms that are first to master this key concept stand to reap the greatest rewards. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

$287.00
Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

FDA’s Work Plan ... the 21st Century Cures Act ... and You - Webinar CD/Transcript

$287.00
The 21st Century Cures Act is a mega-complex set of compromises that Congress mandated. Right now, behind closed doors, the FDA is figuring out how to implement it. Every FDA-regulated health sciences company will be affected. View

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