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The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Health Law Advisor

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

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States and Feds Signal Big Changes to Telehealth Prescribing

Health Law Advisor

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

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Getting it Right on PMA Preemption

Drug & Device Law

The Court noted the rigorous process for PMA approval, emphasizing that the FDA spends an average of 1,200 hours reviewing an application for PMA. Describing the role of the FDA, the Court recognized that the FDA may “approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”

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Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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CPAP MDL Overinflates Plaintiffs’ Claims

Drug & Device Law

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. 2008) (applying the rule; rejecting distinction that “this is a ‘no warning’ case as opposed to an inadequate warning case”), aff’d , 321 F. Sinclair v.

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Thinking About the FDA’s Alternative Summary Reporting Program

Drug & Device Law

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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PMA Preemption Guts Ohio Case Down to Narrow Failure to Warn Claim

Drug & Device Law

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since. 312 (2008).

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