Changing Our Minds: Reforming the FDA Medical Device Reclassification Process

Food and Drug Law Journal | Volume 73 | Number 1

Changing Our Minds: Reforming the FDA Medical Device Reclassification Process2021-04-21T15:48:34-04:00

Get Real: Organic Marketing Under USDA’s Proposed Promotion & Research Agreement

Food and Drug Law Journal | Volume 72 | Number 4

Get Real: Organic Marketing Under USDA’s Proposed Promotion & Research Agreement2021-04-21T15:57:02-04:00

When the Alpha is the Omega: P-Values, “Substantial Evidence,” and the 0.05 Standard at FDA

Food and Drug Law Journal | Volume 72 | Number 4

When the Alpha is the Omega: P-Values, “Substantial Evidence,” and the 0.05 Standard at FDA2021-04-21T15:59:31-04:00

Brand Name Preemption: The New Frontier In Pharmaceutical Product Liability Litigation

Food and Drug Law Journal | Volume 72 | Number 4

Brand Name Preemption: The New Frontier In Pharmaceutical Product Liability Litigation2021-04-21T16:10:23-04:00

Getting by with a Little Help from Their Friends: FDA Using External Experts to Enhance Biomarker Qualification and Enable Precision

Food and Drug Law Journal | Volume 72 | Number 4

Getting by with a Little Help from Their Friends: FDA Using External Experts to Enhance Biomarker Qualification and Enable Precision2021-04-21T16:16:01-04:00

Remarks by Acting FDA Commissioner Stephen M. Ostroff, MD (Open Access)

Food and Drug Law Journal | Volume 72 | Number 3

Remarks by Acting FDA Commissioner Stephen M. Ostroff, MD (Open Access)2021-07-22T15:48:12-04:00

The Role of Patient Participation in Drug Approvals: Lessons from the Accelerated Approval of Eteplirsen (Open Access)

Food and Drug Law Journal | Volume 72 | Number 3

The Role of Patient Participation in Drug Approvals: Lessons from the Accelerated Approval of Eteplirsen (Open Access)2021-07-22T15:48:22-04:00
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