Submissions and Approvals

ARTICLES

CHMP Endorses Six Medicines for Approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended six medicines, including an orphan drug, for approval at its March meeting, in addition to three recommendations for extensions of indications. Read More

PRODUCTS

Top Tips for Dealing with the FDA - Webinar Recording/Transcript

$287.00
The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed. But you have a say in the matter. You can control this all-important relationship to your advantage. View

Precision Medicine: Challenging the Regulatory Landscape - Webinar Recording/Transcript

$287.00
“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge. View

The Fast Track to Drug Approval: Five FDA Pathways for Expedited Review

$397.00
The FDAnews report The Fast Track to Drug Approval outlines the five pathways — Fast-Track Designation, Breakthrough Therapy Designation, Regenerative Advanced Therapy Designation, Priority Review and Accelerated Approval. View

Regenerative Medicine: Steps to Accelerate Development

$397.00
Regenerative Medicine outlines the RMAT pathway and breaks down requirements regenerative medicine developers must meet to qualify. The FDA granted RMAT designation to 12 organizations in 2017 — the first year of the program. Now is the time to get in the mix, work with the FDA to develop the program and improve your chance of being one of the next RMAT designees. View

Extractables and Leachables: 101 - Webinar Recording/Transcript

$287.00
Once confined to the fringes of FDA regulation, extractables and leachables are now in sharp focus. Driven by ICH Q3D guideline compliance requirements, plus a substantial shift in metal impurity standards, the FDA now expects compliance in nearly all dosage forms; and scrutiny extends to materials such as manufacturing equipment and dosing devices. View

Risk Evaluation and Mitigation Strategies (REMS) - Webinar Recording/Transcript

$287.00
Drugmakers’ latest Washington headache involves REMS. Changes are afoot inside the FDA and the halls of Congress, reaching all the way into the office of FDA Commissioner Gottlieb. View

Choosing the Right Drug Approval Pathway - Webinar Recording/Transcript

$287.00
The 21st Century Cures Act has ushered in a new era of business friendliness. Helped along by a pro-business White House and Congress, the FDA wants to help get your new drugs to market. View

Guide to FDA Drug Safety Regulation, 2018 Edition

$397.00
The FDA has upped its drug safety game since the last edition of Guide to FDA Drug Safety Regulation, adding more than 30 new, revised and finalized pharmacovigilance guidances, 12 of them in 2015-2017 alone. View

Regenerative Medicine - Webinar Recording/Transcript

$287.00
The FDA has thrown out 25 years worth of regenerative-medicine regulation. In November the agency issued new rules aimed at clearing a path to market for new therapies. But the ink is barely dry, and pitfalls exist. Right now, wouldn’t it be great to have a knowledgeable lawyer guiding your way? View

Lean Management to Improve Quality & Compliance - Webinar CD/Transcript

$287.00
“Lean management” has come to the drug and device world, improving quality, ensuring compliance and boosting profits for those who adapt its ways to the production floor. If you’re not among them yet, then listen up. View

Sensors and Wearables in Clinical Trials - Webinar Recording/Transcript

$287.00
There’s a transformation going on in the clinical trials world. It’s called mobile health (“mHealth”), and it entails use of smartphones, sensors and wearables to monitor trial subjects in ways not previously possible. View

Generic Drug Development: A Guide to FDA Regulation

$397.00
Generic Drug Development contains all of the FDA’s generics-related guidances, plus internal agency policies on reviewing applications, instructions for challenging patents and even lists of branded drugs with expired patents and no generic competition. View