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21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [read post]
21 May 2024, 10:00 pm
While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties. [read post]
21 May 2024, 9:04 pm by News Desk
The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
21 May 2024, 7:58 pm by Kurt R. Karst
  We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I. [read post]
21 May 2024, 1:38 pm by Laura Ray
Department of Justice (DOJ) Drug Enforcement Administration (DEA) recently announced it is proposing a rule to transfer marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA). [read post]
21 May 2024, 12:49 pm by Yosi Yahoudai
The Los Angeles Police Department said the case is open and ongoing, and confirmed it has been in contact with the Drug Enforcement Administration and U.S. [read post]
21 May 2024, 11:42 am by Yosi Yahoudai
Drug Enforcement Administration have been investigating the actor’s death for several months, trying to determine the source of the ketamine found in Perry’s system. [read post]
Other types of LDTs that can benefit from FDA’s enforcement discretion include Human Leukocyte Antigen (HLA) tests that are designed, manufactured, and used within a CLIA-certified laboratory, tests intended solely for law enforcement purposes, and LDTs manufactured and performed within the Department of Defense and the Veterans Health Administration. [read post]
20 May 2024, 1:07 pm by David Pozen
Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug. [read post]
20 May 2024, 12:34 pm by Michael Lowe
  Origins of the Investigations into the Accused Investigations begin on the desks of employees who are tasked with the collection and providing of information to federal prosecutors (Assistant United States Attorneys, or “AUSAs”) at any one of a number of federal agencies, operating independently or in joint efforts, explained by the Department of Justice (DOJ) to include: The Federal Bureau of Investigation (FBI); The Drug Enforcement Administration… [read post]
20 May 2024, 12:14 pm by Yosi Yahoudai
That program has been extended twice now by the Drug Enforcement Administration and the U.S. [read post]
20 May 2024, 8:40 am by David Pozen
The book notes that “if we turn our gaze from procedure to substance—from questions about how criminal laws are enforced to questions about what may be criminalized in the first place—the drug cases look less exceptional than representative, and in some areas formative, of the broader legal landscape” (p. 159). [read post]
19 May 2024, 9:05 pm by The Regulatory Review
Sep 21, 2023 | HHS Selects Drugs for Medicare Price Negotiation | Biden Administration introduces price regulation to the pharmaceutical industry. [read post]
17 May 2024, 3:00 am by Yosi Yahoudai
When they did, it tended to be in cases in which they discovered guns or drugs. [read post]
17 May 2024, 3:00 am by Yosi Yahoudai
In reality, the myth of the all-powerful “czar” to tackle specific policies — from drugs and terrorism to economic growth to homelessness — is largely a media creation that first took root in FDR’s White House and spread to future administrations and to towns and counties across America. [read post]
16 May 2024, 9:05 pm by Dan Flynn
Food and Drug Administration (FDA) recalls rose 27.6 percent over the previous quarter for 134 events during the first period of 2024. [read post]
16 May 2024, 7:00 pm by Guest Blogger
The history we excavate in fact bears on arguments in two abortion cases now before the Court —Food and Drug Administration v. [read post]
16 May 2024, 4:02 pm by Kurt R. Karst
Houck —Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). [read post]
16 May 2024, 12:30 pm by Yosi Yahoudai
The Drug Enforcement Administration will take public comment on the proposal to move marijuana away from its current classification as a Schedule I drug, alongside heroin and LSD. [read post]