RU-486 Under Attack: Abortion Groups Sue States To Restrict Off-Label Use
Eight years after FDA approved RU-486, two states have engaged in a legal battle to restrict patient access by attempting to prevent physicians from prescribing the abortion pill for off-label uses
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States Take Unusual Actions To Control On-Label Drug Supply Amidst COVID-19 Shortages
Sixteen US states have issued executive orders or other mandatory directives to preserve hydroxychloroquine and chloroquine for non-COVID-19 patients, while 26 states have issued similar voluntary guidance. The federal government is reserving some of the strategic national stockpile supply of the drugs for non-COVID-19, as private players in the supply chain also join in the efforts to balance on-label use with COVID-related demand.
Teva’s ‘Skinny Label’ Dispute Edges Toward Supreme Court With Government’s Backing
US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after missed prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.