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…what many nutrition experts and health advocates, including Mrs. Obama, have been suggesting: Americans should shift their diets to more plant-based foods, such as legumes, seeds, nuts, whole grains, vegetables and…
…This statutory provision provides that: (a) Whoever, without the consent of the patentee, marks upon, or affixes to, or uses in advertising in connection with anything made, used, offered for…
…the generic applicant’s proposed RLD was based in the context of ANDA No. 75-250 for Prednisolone Sodium Phosphate Oral Solution. In that case, FDA approved WE Pharmaceuticals, Inc.’s (“WE’s”) ANDA…
…CPSIA to examine and assess, in consultation with consumer groups, juvenile product manufacturers, and independent child product engineers and experts, the effectiveness of the ASTM toy safety standard, ASTM-F963-07. Accordingly,…
…open to the public; (2) price concessions and direct sales to hospitals, clinics, and physicians, except for inhalation, infusion, or injectable drugs, or except as determined by CMS; and (3)…
…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…
…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…