US Supreme Court’s EPA Ruling Expected To Have Limited Impact On FDA Regulations
Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.
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Supreme Court Rules Narrowly Against Medicare Payments Cuts To 340B Hospitals
The decision doesn’t directly impact manufacturers or the 340B discounts they are required to provide – and does not address the potentially much broader regulatory issue of whether the Supreme Court’s so-called Chevron doctrine should be changed.
FDA’s Office Of Generic Drugs Gets New Permanent Director And Oversight Designee
Iilun Murphy, a 15-year agency veteran, takes helm of OGD. Jacqueline Corrigan-Curay to assume oversight of the office and report to CDER director.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.