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…Commitment to User Safety (“FOCUS”) Program. Prescribers and patients must sign an enrollment form detailing the responsibilities of both, while pharmacies must, among other things, only dispense Onsolis via a…
…in Teva Pharms. USA, Inc. v. Novartis Pharma. Corp., in which the court, consistent with the Supreme Court’s Medimmune decision, rejected the “reasonable apprehension of imminent suit” test the court…
…agreed to in principle prior to the Administration change. Thus, given the expectations for this administration, one can only expect increased state AG and FDA collaboration in the coming months….
…of pending ANDAs and 505(b)(2) applications. The law was amended by § 301 of Pub. L. No. 110-316 (2008), and again by FDASIA § 1135, which, among other things, changed…
…generic versions of PRECOSE (acarbose) Tablets. Comments on FDA’s draft vancomycin HCl bioequivalence recommendations are due by February 17, 2009; however, ViroPharma has requested an extension of the comment period….
…(e.g., glucose-6-phosphate dehydrogenase deficiency), closer follow-up for blood hemoglobin levels and reticulocyte counts should be implemented (see PRECAUTIONS). Alternatively, other therapies for acne than ACZONEÔ Gel, 5%, may be considered….
…2007, would require that menus disclose next to the name of the food the number of calories, grams of saturated fat plus trans fat, and milligrams of sodium contained in…
…product. The class action lawsuit, brought on behalf of a certified class of persons “who purchased Neurontin, or its generic equivalent, gabapentin, in the Commonwealth of Pennsylvania” for unapproved uses,…
Preemption of state law concerning FDA-regulated products (drugs, devices, and foods) has been the hot topic over the past few weeks. First, on February 20, 2008, the U.S. Supreme Court…
…Almost six months later, on August 8, 2006, Apotex began commercially marketing its generic clopidogrel bisulfate drug product at-risk of an adverse court decision, thereby triggering the company’s 180-day exclusivity. …
…summary judgment, that they complied with these regulatory requirements. The Seventh Circuit, however, found that the trial court abused its discretion in imposing the maximum allowable monetary penalties under the…
…cares about is like “location,” “location,” “location” in the real estate purchase context. It’s about “substantial evidence,” “substantial evidence,” “substantial evidence”. So whether we like it or not, or whether…
Every so often something comes across our desk that is so comical that we feel compelled to share it with others in the food and drug community who will also…
…notice: [Boehringer] claims December 15, 2009, as the date the new drug application (NDA) for PRADAXA (NDA 22–512) was initially submitted. However, FDA records indicate that NDA 22–512, received December…
…federal law.” Statement from President Biden on Marijuana Reform, White House (Oct. 6, 2022). Media outlets report, and HHS and Drug Enforcement Administration (“DEA”) officials confirm, that HHS has recommended…