Archived Publication Archives - Page 9 of 18 - Food and Drug Law Institute (FDLI)

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

Archived Publication, Drugs, Medical Devices, Biologics, Food and Drug Law Journal, Publications, Volume 72.4

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 FDAadmin2021-04-21T15:59:31-04:00

The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls
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The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls

Archived Publication, Drugs, Medical Devices, Biologics, Publications, Update Magazine, Update November/December 2017

The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls

Update Magazine | September/October 2017

The Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfallsadmin2018-06-26T13:16:44-04:00

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

Archived Publication, Drugs, Medical Devices, Biologics, Food and Drug Law Journal, Publications, Volume 72.4

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 Litigationadmin2021-04-21T16:10:23-04:00

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI
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The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI

Archived Publication, Drugs, Medical Devices, Biologics, Publications, Update Magazine, Update November/December 2017

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VI

Update Magazine | November/December 2017

The Value of FDA Pre-Submission Meetings & Enhancements under PDUFA VIadmin2018-06-26T13:16:44-04:00

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

Archived Publication, Drugs, Medical Devices, Biologics, Food and Drug Law Journal, Publications, Volume 72.4

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 Precisionadmin2021-04-21T16:16:01-04:00

Letter to the Editor
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Letter to the Editor

Archived Publication, Food and Drug Law Journal, Food, Dietary Supplements, Cosmetics, Publications, Volume 72.4

Letter to the Editor

Food and Drug Law Journal | Volume 72 | Number 4

Letter to the Editoradmin2021-04-21T16:19:21-04:00

Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs
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Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs

Archived Publication, Drugs, Medical Devices, Biologics, Publications, Update Magazine, Update September/October 2017

Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugs

Update Magazine | September/October 2017

Compounding the Off-Label Promotion Debate: How FDA Could Regulate the Promotion of Unapproved Drugsadmin2017-11-16T13:49:29-05:00

Intellectual Property for the Food and Drug Law Professional: Issues that Arise in the Product Development Process
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Intellectual Property for the Food and Drug Law Professional: Issues that Arise in the Product Development Process

Archived Publication, Drugs, Medical Devices, Biologics, Publications, Update Magazine, Update September/October 2017

Intellectual Property for the Food and Drug Law Professional: Issues that Arise in the Product Development Process

Update Magazine | September/October 2017

Intellectual Property for the Food and Drug Law Professional: Issues that Arise in the Product Development Processadmin2017-11-16T13:49:39-05:00

The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?
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The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?

Archived Publication, Drugs, Medical Devices, Biologics, Publications, Update Magazine, Update September/October 2017

The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?

Update Magazine | September/October 2017

The “New” NDC: Are You Aware of FDA’s Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?admin2017-11-16T13:49:48-05:00