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…orders to the local DEA office. 21 C.F.R. § 1301.74(b). Suspicious orders include orders of unusual size, orders that deviate substantially from a normal pattern and orders of unusual frequency. …
…approval. Essentially, Apotex’s argument rests on the premise that the New York District Court’s order only “purports to reset the effective date of [the company’s] approval to the expiration of…
…Composition Patents and the Combination Therapy Patents, expire in 2016. Watson, and apparently Mylan (ANDA No. 076801) and Ranbaxy (ANDA No. 076800), all submitted ANDAs to FDA on July 15,…
…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….
…complainant who, for example, submitted an unreliable or inadequately documented complaint to the Agency, CDRH now has committed to “follow-up communication” and a tracking system. This will allow submitters to…
…eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants. Requiring Online Submission of Applications for and Renewals of…
…(see our blog post here), the regulated community has been eager to engage with FDA to understand both the procedural and substantive requirements for submitting an OTC monograph order request…
…at the agency and the Office of Diversion Control. Ms. Carter stated that the agency is considering issuing further clarification of suspicious order requirements, possibly a regulation specifying the format…
…FDA states is compounding ‘on’ receipt of a valid prescription order consistent with Section 503A(a)(1). Compounding Before Receipt of a Valid Prescription Order A drug may be compounded before…
…this brief provides the clearest statement of FDA’s limited authority to compel a recall. We previously described (here and here) the litigation commenced by Hospira, Inc. (“Hospira”) wherein the company…
CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration. However, until today…
…material difference between the phrases.” Final Order at 14,967 n.38 (citing cases). The Combining of 21 U.S.C. § 823(f)’s Factor 2 and Factor 4 Of the five public interest factors…
…2021, unless DEA receives significant adverse comment. DEA will withdraw the rule by September 20, 2021, if it receives significant adverse comment. Electronic comments must be submitted, and written comments…
…rules under the Executive Order by November 26, 2020, absent a waiver. See M-20-31, Implementation of Section 6 of Executive Order 13924 (Aug. 31, 2020). There is no doubt that…
…proposes the use of a single sheet DEA-222 order form that will require execution by registrants in the same manner as the three-part forms. DEA will issue the order forms…