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24 Aug 2023, 9:41 am
In the meantime, the European Medicines Agency granted Mylan an EU-wide central marketing authorisation for a generic version of Biogen’s drug on 13 May 2022. [read post]
22 Aug 2023, 9:00 pm
Stakeholder and industry groups are also actively releasing guidance, despite the lack of enforceability, which materially limits its implementation. [read post]
22 Aug 2023, 6:44 pm
We speculated that, “[g]iven the drop in OPDP enforcement letters, NAD may represent a new venue for industry looking to challenge competitor Rx drug DTC advertising claims. [read post]
21 Aug 2023, 9:00 pm
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
21 Aug 2023, 7:47 am
Cohen has authored several law review articles on Federal agency rulemaking, including Congressional Review of Agency Regulations. [read post]
21 Aug 2023, 7:47 am
Cohen has authored several law review articles on Federal agency rulemaking, including Congressional Review of Agency Regulations. [read post]
18 Aug 2023, 1:29 pm
It's too late to challenge the FDA's 2000 approval of the abortion-causing drug mifepristone, says the Fifth Circuit, but agency decisions in 2016 and 2021 to loosen some restrictions on its availability might have violated the Administrative Procedure Act. [read post]
17 Aug 2023, 9:05 pm
Environmental Protection Agency (EPA) denied two petitions from environmental and community groups seeking changes to its enforcement of the Clean Water Act as it relates to concentrated animal feeding operations (CAFO). [read post]
16 Aug 2023, 9:00 am
They understand the nuances of trucking regulations and can work with law enforcement agencies to obtain evidence of impaired driving, ensuring that the negligent parties are held accountable. [read post]
15 Aug 2023, 9:01 am
During the meeting, employee benefit attorneys Committee Co-Chair, Cynthia Marcotte Stamer, and Committee Vice Chairs Jacquelyn Meng Abbott, and Allison Moody will lead a discussion of the new guidance package including: The Report, Fact Sheet and selected MHPAEA litigation enforcement developments The recently Proposed Regulations and Technical Release; Other MHPAEA compliance developments and tips; and Possible areas of concern on which the RPTE Employee… [read post]
15 Aug 2023, 6:20 am
Food and Drug Administration is scoffing at a “Doe” lawsuit filed by a company attorney trying to prevent being identified in an agency inspection report on the grounds disclosure would cause irreparable harm to the lawyer’s reputation and career.The unusual “reverse FOIA” case, is based on flimsy legal arguments that don’t come close to meeting the narrow public-disclosure exceptions contained in the… [read post]
14 Aug 2023, 9:00 pm
The Food and Drug Administration is continuing its use of import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
14 Aug 2023, 7:50 pm
Of those, only about a quarter (26%) resulted in Warning Letters, less than a quarter (19%) resulted in imposition of import alerts (restricting or prohibiting imports into the United States of drugs from a specified facility), slightly more (24%) resulted in regulatory meetings with the agency, and the plurality (29%) resulted in FDA exercising “regulatory discretion,” which means a decision not to take enforcement action. [read post]
14 Aug 2023, 2:49 pm
Usually, the IRS will only approve an offer if it is equal to at least the amount the agency would be able to collect if it enforced collection actions against you. [read post]
14 Aug 2023, 1:20 pm
As a part of this work, she regularly advises businesses and government leaders on an on-demand and ongoing basis about preparation of workforce, health care and other business and government policies and practices to deal with management in a wide range of contexts ranging from day to day operations, through times of change and in response to complaints, investigations and enforcement. [read post]
11 Aug 2023, 10:11 am
Group health plans and individual and group health insurance subject the federal No Surprises Act (“NSA”) are likely to experience continued delays in their ability to finalize certain claims liability determinations and pay providers for health claims submitted for arbitration under the NSA-established Federal Independent Dispute Resolution (“IDR”) medical claims review process as a result of an August 3, 2023 federal court ruling even as the federal agencies… [read post]
10 Aug 2023, 9:05 pm
Immigration and Customs Enforcement issued an interim rule in an effort to modernize immigration bonds. [read post]
10 Aug 2023, 6:11 pm
Countries that accede to the convention would promise to empower their own law enforcement in new ways, but also to allow new kinds of cooperation with foreign government agencies, with shockingly little responsibility to ensure that such cooperation isn’t abused. [read post]
10 Aug 2023, 6:11 pm
Countries that accede to the convention would promise to empower their own law enforcement in new ways, but also to allow new kinds of cooperation with foreign government agencies, with shockingly little responsibility to ensure that such cooperation isn’t abused. [read post]
10 Aug 2023, 7:13 am
In the last couple of years, each Fall, FDA has been updating a list of machine learning applications in health care that the agency has cleared or otherwise approved.[1] As of last Fall, the list included 521 products dating back to 1995. [read post]
