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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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.
Attorneys say the biggest step FDA could take to expand access to medication abortion would be to eliminate REMS requirement for mifepristone. Timeline notes steps Biden administration and Congress have taken since the Supreme Court’s ruling overturning the right to an abortion.
FDA guidances have provided ‘major step forward’ for use of social media data, Roche researcher notes. Agency staffer offers checklist for collecting patient experience data in this realm.