Menu
Your search for “ ���� Cattle Ivermectin ���� www.Ivermectin-Stromectol.com ���� Guinea Pig Mites Ivermectin ���� Oral Ivermectin , Ivermectin Pi” returned the following results.
…Nathan a sales representative, had not pled fraud with particularity. Nathan filed a cert. petition alleging a split among the circuits. Specifically, Nathan claimed that the 4th, 6th, 8th, and…
…of our previous posts here, here, here, and here). In this case, the Court latched onto a comment from a discussion that occurred during oral argument regarding the fact that…
…over 69,000 public comments. The Commissioner gave no indication that the reconsideration would result in an extension of the compliance date beyond May 7, 2018. The forthcoming guidance, he said,…
…years), and that continuous manufacturing is more reliable, safer, more efficient (i.e., can drive down manufacturing costs), and allows manufacturers to respond much quicker to changes in demand, thereby theoretically…
…Balance Between Innovation and Access,” is part of Commissioner Gottlieb’s Drug Competition Action Plan, which he indicated was forthcoming during a May 2017 House Appropriations Committee hearing. The meeting is…
…publications, reference texts, or clinical practice guidelines Communication, both proactive and reactive, or information regarding a manufacturer’s research and development efforts Communication, both proactive and reactive, of scientific, medical, or…
…because of the order in which it was approved, those circumstances might render the FDA’s policy arbitrary and capricious.” In addition to PREPOPIK, Ferring identified STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir…
…80 Fed. Reg. 57756, 57757 (Sept. 25, 2015). This clause, however, appears nowhere in the preamble. Instead, there are citations to several court opinions that enumerate the types of information…
…on some decisions, either because companies exchanged waivers of 3-year exclusivity (e.g., single-entity, extended-release hydrocodone drug products – see here), or because another obstacle, such as a 30-month litigation stay,…
…to DESIs 6290, 6514, 11935, and 12152 were closed on January 1, 2011, and March 3, 2011 (76 FR 1175; 76 FR 11790). Benzocaine, Butylamine benzoate, and tetracaine hydrochloride (e.g….
…“are not included in this publication.” In Section 1.2 (Therapeutic Equivalence-Related Terms) of the Preface, FDA clarifies certain common terms, such as “pharmaceutical equivalents” and, in particular, “strength” to comport…
…container does not include other ingredients.” FDA notes that “if the drug is manipulated in any other way, including if the drug is reconstituted, diluted, mixed, or combined with another…
…and gravitas. No, really. On December 12, 2016, demonstrating that they’re not dead yet, the Office of Prescription Drug Promotion (OPDP) issued two letters relating to television ads, one to…
…(“Gilead”), the sponsor of NDA 203100 for STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) Tablets (approved on August 27, 2012), submitted a Citizen Petition (Docket No. FDA-2016-P-3312) to FDA in…
…an NCE and a previously approved drug – and specifically, to Ferring’s PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16, 2012)…