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…dates for fee payment, exceptions to certain fees, the process for submitting fee payments, the consequences of failing to pay the required fees, and the process for submitting refund requests…
…in the United States. For the remaining 12 active ingredients, cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone, and avobenzone, FDA has not identified safety concerns,…
…formulation contains at least one active ingredient in common with the initial brand name listed drug.” Examples in the regulation include extended-release formulations, new strengths, dosage forms, routes of administration,…
…Clarification of Listing of “Tetrahydrocannabinols” in Schedule I, 68 Fed. Reg. 14,114, 14,119 (Mar. 21, 2003), and one that exempted hemp fiber, seed and oil products containing THC not intended…
Earlier this week, Senator Sherrod Brown (D-OH) announced the introduction of S. 3633, the “Transparency in Drug Labeling Act.” The bill, also know as the “COOL Pharmaceutical Bill,” would amend…
…Show Cause Why Defendant Should Not Be Held in Contempt, No. 07-cv-00001, Docket No. 4 (D.N.J. Sept. 12, 2014). Specifically, many commentators fear that the FTC is attempting to impose…
…Colorado Attorney General John W. Suthers, charged Dalbey, Marsha Kellogg, and others with misleading consumers about how much money they could make using the program. In the complaint, the FTC…
…formulation, dosage form, potency, route of administration, indication for use, or intended patient population for their 20 mg/ml morphine sulfate oral solution since 1938, plaintiffs’ drug does not qualify for…
…Labs., Inc. v. Thompson, 389 F.3d 1272, 1281 (D.C. Cir. 2004), Dobbs v. Wyeth Pharms., 797 F. Supp. 2d 1264, 1270-71 (W.D. Okla. 2011). In ordering FDA to initiate withdrawal…
…17th and granted the company 180-day exclusivity. On August 24th, Watson filed an Amended Complaint, and on August 27th, Watson filed a Motion for Summary Judgment asking the court to…
…general information about postmarket surveillance studies (e.g., application number, applicant name, device name, status) and reporting information (e.g., interim and final report schedule, receipt dates, status category), which were listed…
…the Executive Order and the OMB memorandum apply to all federal agencies, including FDA, FTC, DEA, CPSC, and USDA. In this post, we will focus on one of those agencies,…
…controlled substances,” and Factor 4 looks to the applicant’s “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. § 823(f)(2), (4). In the Administrator’s view,…
On November 27, 2007, the Drug Enforcement Administration (“DEA”) issued a proposed rule to implement a new format for DEA Official Order Forms (so-called “DEA-222s”). DEA requires registrants to acquire…
…FDC Act § 505(j)(5)(B)(iii), which states, in relevant part: If the applicant made a [paragraph IV certification], the approval shall be made effective immediately unless, before the expiration of 45…