Searching Content by Abeba Habtemariam from Arnold & Porter ordered by Published Date Descending.
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Status Of Food And Drug Administration Programs And Activities During The Current Government Shutdown
The following chart provides an update (as of January 11, 2019) on the status of Food and Drug Administration (FDA) activities and programs ...
United States
17 Jan 2019
FDA Seeks Comments On The Regulatory Framework For Prescription Drug-Use-Related Software
Virtually all pharmaceutical companies have been exploring the use of various software tools in both drug development and in conjunction with marketed products.
United States
3 Dec 2018
FDA Finalizes Guidance Documents On Payor Communications And Communications Consistent With Labeling
On June 12, 2018, the US FDA issued revised, final versions of two guidance documents, "Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers"...
United States
18 Jun 2018
National Right To Try Legislation Passes Congress
On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina Right to Try Act of 2017 (S. 204) ...
United States
25 May 2018
Trump Administration Issues Blueprint To Lower Drug Prices And Reduce Out-Of-Pocket Costs
On May 11, the Trump Administration unveiled its much anticipated plan for reducing drug prices and patient out-of-pocket costs, with a "Blueprint" document ...
United States
16 May 2018
Upcoming US FDA Marketing Status Reporting Deadline For NDA And ANDA Holders
Holders of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) should be aware of an upcoming deadline that requires an affirmative submission ...
United States
30 Jan 2018
FDA's 21st Century Cures Act Guidance Documents Clarify The Landscape For Digital Health Innovation
On December 7, 2017, the FDA announced several digital health policy documents designed to "encourage innovation" and "bring efficiency and modernization" to the agency's regulation of digital health products.
United States
20 Dec 2017
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