…not necessarily containing the same inactive ingredients, and that meet the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity…

…required under the CSA, 21 USC § 811(b), (c) and (f), on December 28, 2016, HHS provided DEA with its “eight-factor” analysis recommending to reschedule Syndros and dronabinol oral solutions…

…a “nonambulatory pig” is not “type of meat.”  Moreover, the Court found that the FMIA ensures the safety of meat and protects the health of the consumers, including California’s citizens….

…surgery, intubation, acute illness, etc.). In 2011, FDA determined that Arbor’s NYMALIZE (nimodipine) Oral Solution, 60 mg/20 mL (NDA 203340), was clinically superior to Bayer’s NIMOTOP (nimodipine) Capsules (NDA 018869)…

…drug is different from a previously approved orphan drug, thus making the company’s product eligible for orphan drug designation and orphan drug exclusivity (and, where applicable, the ability to “break”…

…failing to hold that Ms. Levine’s common law claims were preempted, because: “(1) Wyeth would have been unable to comply with both Vermont’s common law duty to foreclose IV push…

…the letter) “all records relating to any posting on Cafepharma.com related to the ENHANCE study, including but not limited to, names, addresses, phone numbers, and e-mail and internet protocol addresses…

…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…

…professionals (i.e., designated agents) to transmit a practitioner’s oral prescription for a schedule II-IV controlled substance to DEA-licensed pharmacies.  In exchange, nursing homes, practitioners, and pharmacies would have to account…

…would reduce patent challenges, decrease competition, and harm consumers. The FTC, in its reply brief filed last week, got in the last word on the case, saying that the “quick…

…including Monday, May 11, 2015, to and including Friday, June 3, 2016) is far too long a period.  “In recent cases with expedited briefing, as is the case here,” notes…

…100 mg/5 mL (NDA No. 200535), and an NDA for Oxycodone HCl Oral Solution, 5 mg/5mL (NDA No. 201194).  According to FDA, unapproved drug products containing Oxycodone HCL, a derivative…

…effective June 17, 2010, and was to be fully implemented by June 17, 2011.  Thus, at the time of the audit, the industry had barely two years of experience with…

Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures.  The FTC released the original guide 13 years ago, when mobile phones…

…the Dot Com Disclosures since May 2011.  According to Mary Engle (Associate Director, FTC Division of Advertising Practices), the FTC is accepting written comments on the issue through July 11,…