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Akerman LLP - Health Law Rx

FDA’s Safe Importation Action Plan May Give Florida’s Drug Import Program a Pathway to Approval

Akerman LLP - Health Law Rx on

At both the federal level and within Florida, there are the beginnings of the seeds of change regarding drug importation policies.  President Trump and Governor DeSantis have both been HUGE supporters of drug importation as a...more

Mintz - Health Care Viewpoints

In Policy Reversal, HHS and FDA Propose Plan to Import Foreign Drugs

Mintz - Health Care Viewpoints on

On July 31, 2019, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published a proposal, called the Safe Importation Action Plan, to allow certain entities to import...more

K&L Gates LLP

340B Update: HRSA Delays Final Rule on 340B Pricing and Manufacturer CMPs Yet Again

K&L Gates LLP on

On August 21, 2017, the Health Resources and Services Administration (“HRSA”) published a Notice of Proposed Rulemaking to further delay the effective date of final rules on drug pricing calculations and civil monetary...more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

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