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…impact on medical care. The DEA must establish APQs on an annual basis which limit the total amount of a certain drug that can be manufactured in a given year….
…on hold. All FDA requests for additional information will be made interactively with an expectation that the sponsor responds quickly. The final decision is intended to be made within 60…
…research-grade marijuana. Then, in August 2016, DEA stated that along with the National Institutes on Health and FDA it “fully supports expanding research into the potential medical utility of marijuana…
…national practice areas – and a total of 2,118 firms received a national law firm ranking. We are proud that the ‘Best Law Firms’ rankings continue to act as an…
…to form the products,” and (3) “fresher and healthier . . . .” The Plaintiff also alleges that Kind’s claims of “no added sugar” are false or misleading. The Song…
…letter from FDA to Abigail Alliance, the Agency commented that accepting Abigail Alliance’s proposal “would upset the appropriate balance that [it is] seeking to maintain, by giving almost total weight…
…and a “243% increase in the annual number of foreign device inspections” during the same time period. Report at 2. FDA also gives itself credit for implementing the Medical Device…
…disgorgement of profits in most such cases. In many cases, the FTC also seeks and obtains “emergency” relief such as a total freeze of the defendants’ assets. All of this…
…injections were alleged to have led to the partial or total blindness of at least three patients, and in the second case, the therapies were alleged to have led to…
…with a pharmacy as the amount the pharmacy will receive, in total, for a Part D drug, and it is also the pharmacy’s price to the enrollee, upon which the…
…papaverine topical gel for the “treatment of sexual dysfunction in spinal cord injured patients.” FDA revoked the designation on September 16, 1993 after additional information showed that the potential target…
…the payment of a claim by the government” when “there is no allegation that the FDA withdrew or even suspended product approval upon learning of the alleged misrepresentations,” the Nargol…
…statutes alleging that Defendants manufactured and dispensed prescription drugs that did not comply with certain federal laws requiring child resistant packaging. Specifically, according to Plaintiffs, Defendants violated the Poison Prevention…
…exclusive approval, as appropriate, for those additional subsets from the date of such additional marketing approval(s). Before obtaining such additional marketing approval(s), the sponsor in this instance would not need…
…crucial because the compliance date for the final rules is July 26, 2018 (smaller businesses with annual food sales of less than 10 million dollars have until July 26, 2019)….