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Brenda Sandburg

New York, NY
Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She spent 10 years writing for legal publications between stints at The Pink Sheet and blends these experiences to provide in-depth analysis of events. An aspiring photographer, she enjoys taking photos to accompany news stories.
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Latest From Brenda Sandburg

US FDA Launches Study Of Prescriber Perceptions About Abuse-Deterrent Opioids

The agency is assessing whether to use different language to describe addiction and abuse deterrence.
Drug Safety Neurology

Drug Sponsors Are On Schedule With Most Post-Approval Studies

US FDA's Gottlieb touts use of real world evidence as report shows vast majority of postmarketing requirements and commitments progressing on schedule.
Post Market Regulation & Studies Regulation

PMRS Continues Campaign Against Other Abuse Deterrent Opioid Products

Latest citizen petition seeks to halt US FDA approval of Mallinckrodt's immediate release oxycodone abuse deterrent formulation; user fee action date is Nov. 16.

Drug Review Neurology

Mallinckrodt's Abuse Deterrent Oxycodone IR Narrowly Wins US FDA Panel Backing

"Incremental" step forward is sufficient for product to be labeled as deterring abuse by nasal, but not intravenous route, advisory committee members conclude.
Advisory Committees Neurology

US FDA Allows Waiver Of Informed Consent For Clinical Investigations With Minimal Risk

The agency seeks input on the types of qualifying investigations that involve minimal risk. Providing informed consent waivers in these cases, as required by the 21st Century Cures Act, will help advance health-care innovations, FDA says.

Medical Device Clinical Trials

US FDA Allows Waiver Of Informed Consent For Clinical Investigations With Minimal Risk

Agency seeks input on types of investigations that would involve minimal risk, exclusion of waiver to research involving identifiable private information.

BioPharmaceutical Regulation
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