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…lawsuit dropped. Spectrum Pharmaceuticals, Inc. (“Spectrum”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction challenging FDA’s February 24, 2015 denial of a Citizen Petition (Docket…
…how this will work. At a minimum, under the statute, FDA has authority to issue a classification order in response to an accessory classification request. We assume this order will…
…the company met the requirement for granting exclusivity by using FDA’s Formal Dispute Resolution process. As we previously reported, Amgen alleges in the company’s Complaint and Motion for Temporary Restraining…
…different dosing regimens: (1) Single-Dose Therapy (7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb)); and (2) Multiple-Day Therapy (2.5 to 5.0 mg/kg of body weight (1.1…
…the listed drug.” Second, “the terms of the counterclaim provision do not authorize an order compelling the patent holder to change its use code narrative,” just the patent number and…
…the Michigan law, which compelled participation by the plaintiff telephone companies, denied them of their right to a “fair and reasonable rate of return.” Order at 22. As such, that…
…heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated August 13, 2009 did not come until more than 6 years after the date of…
…date listed.) With respect to generic drug approval, the patent statute at 35 U.S.C. § 271(e)(4)(A) states that “the court shall order the effective date of any approval of the…
By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous…
…order is not required, however, if a manufacturer submits a report under section 905(j) of the Act for the new tobacco product (a “905(j) report”) and FDA issues an order…
…Procedures if FDA Seeks Civil Money Penalties and/or No-Tobacco-Sale Orders FDA will file a Complaint with the Division of Dockets Management and will serve the Complaint upon the retailer found…
…was removed from the market at the initiative of FDA or was determined to be misbranded or adulterated by a judicial order. (Both FDA-mandated recalls and judicial orders of this…
…“exposure modification order” or “risk modification order” under section 911(g) of the FDC Act. Under the draft guidance, an exposure modification order can be issued for an MRTP that reduces…
…order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation”…
…collaboration” about the Drug Enforcement Administration’s (“DEA’s”) efforts to combat prescription drug abuse. While voicing strong support of DEA’s efforts to fight prescription drug abuse, the letter states that recently…