Oct 12, 2018
Leela Barham looks at whether FDA approval is expedited when a drug not only secures one or more of the FDA’s expedited development and review methods, but is also when it is designated an orphan drug.
Oct 10, 2018
Use of FDA's options for speedier approval applied to more than half of novel drug approvals in recent years. But which drugs–and from which companies–are being approved faster? Leela Barham reports.
Oct 09, 2018
Congress approves bills with provisions important to FDA and industry, some of which reflect continuing concerns about drug pricing and transparency.
Oct 08, 2018
Leela Barham continues her series of features exploring expedited FDA approvals with a look at the therapy areas and the overlap with orphan drug designations.
Oct 05, 2018
Leela Barham takes a look at the take-up of the existing options to speed up FDA approval.
Oct 05, 2018
There’s been a lot of talk about speeding up drug approval at FDA. Leela Barham takes a look at the speed of approval for each of FDA's expedited development and review methods.
Oct 04, 2018
FDA offers four options to speed up approval and they can be used in combination. But just which of the many combinations offers the fastest approval? Leela Barham reports.
Sep 27, 2018
CDER director plans to start implementation of new review practices by the end of 2018.
Sep 27, 2018
Preparing products for distribution in international markets is far from straightforward. Nancy Pollini looks at what constitutes best practice in managing translations in today’s regulatory affairs environment.
Sep 21, 2018
Dan Rubin discusses how a full-service prior authorization (PA) support program facilitates higher PA submission rates and more prescriptions dispensed.
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