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…the question of whether dietary compliance, and therefore patient health, will benefit from a medical food should be left to the medical community, not to FDA. Indeed, this approach amounts…
…order for the Act to be effective, DEA must prevent patients from ordering from pharmacies that have not met the Act’s requirements. By John A. Gilbert and Larry K. Houck…
…2020, DEA announced a “proactive collaboration with online e-commerce companies” to inform and educate e-commerce companies about the requirements and importance of safeguarding these products and ensuring they do not…
…3. The Special Advisory Bulletin concluded that “HHS’s past approach of promoting voluntary compliance has not been fully effective.” Id. at 4. Accordingly, in order to promote increased compliance with…
By Kurt R. Karst – In what might very well be the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from…
…attempting to trigger 180-day exclusivity for generic versions of the hypertension drug BENICAR (olmesartan medoxomil) Tablets, 5 mg 20 mg, and 40 mg, under the failure-to-market 180-day exclusivity forfeiture provisions…
…Wyeth, acting alone and/or in concert with first generic applicant Teva Pharmaceuticals USA, Inc. (“Teva”) violated Section 2 of the Sherman Act by delaying EFFEXOR XR generic competition. According to…
…of Illinois (Eastern Division) in Abbott Labs. v. Matrix Labs., Inc., No. 09-cv-1586 (N.D. Ill. Nov. 5, 2009) ordered the tolling of the 30-month stay in the context of patent…
Earlier today, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva. …
…order to “provide more time for CMS, states, and manufacturers to implement the new best price and VBP program …,” and also to give CMS more time to complete implementation…
…force PBMs to pass manufacturer rebates through to pharmacies to lower the out‑of‑pocket costs of government beneficiaries at the pharmacy counter. The exclusion from the discount safe harbor had a…
…expensive. User fees alone for a generic drug total $300,000 for the first year compared to only around $7,600 for devices – user fees for drugs approved under the 505(b)…
…FDA’s response to Pacira’s Motion for Preliminary Injunction was due on October 26, the court issued a revised Scheduling Order on October 22. The Order indicated that the parties are…
…Anabolic Steroid Control Act (“DASCA”), adds 25 specific over-the-counter designer substances to the category of “anabolic steroids” classified as Schedule III under the Controlled Substances Act. Senator Orrin Hatch (R-Utah),…
…Reconsideration of a pre-Levine Order granting Perrigo’s Motion for Summary Judgment. The pre-Levine Order found that Gaeta’s state law causes of action were preempted to the extent that they allowed for…