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…were scheduled to file their opposition or an amended complaint by September 19. Meanwhile, as we reported here, FDA Commissioner Scott Gottlieb announced on August 25 that the Agency would…
Last week the U.S. Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin…
…and provide increased access to compounded medications from outsourcing facilities. First discussing the need for compounded medications, the Commissioner states, “Supporting access to compounded drugs made under high production standards…
…that cannabis could only be rescheduled to schedule II in order for the U.S. to comply with its international treaty obligations. Denial of Petitions at 53,688-89, 53,767-68. The U.S. is…
…permitting the sponsor to bring legal action for failure to comply does not indicate that the compliance with the statute is optional. This interpretation is consistent with the statutory purpose…