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…sometimes requiring several separate responses about different issues regarding the same product. Responding to such serial petitions requires the use of substantial FDA resources, on a repeated basis, over a…
…approval could negatively affect public health.” Although FDA does not identify by drug name or application number the particular approval delayed, we suspect that the application at issue was NDA…
…received a total of 194 505(q) petitions, and responded to all but 14 of them within the statutory timeframe (i.e., 180 days or 150 days). That’s a pretty good track…
…FY 2008 through FY 2013, FDA received a total of 131 petitions subject to section 505(q). Over this 6-year period, FDA responded to all but six of the 505(q) petitions…
…each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act (FDCA). Under the terms of the plea deal, David Newbaker was sentenced to 12…
…a normal Pre-Submission, three-to-four questions could relate to a clinical study plan alone without addressing other important questions such as regulatory strategy. The guidance does not state what, if anything,…
…(for a grand total of 1062 PUCs from 1988 to today). The tables below show the year-by-year growth of PUCs. So what general conclusions can be gleaned from the doubling…
…along with the quantity reported in milligrams per serving or, alternatively, declaration of the amount of phosphorus (in mg) in the Nutrition Facts panel. In response to its proposal to…
…the other regarding a detail aid for Schering Corporation’s NASONEX (mometasone furoate monohydrate) Nasal Spray, 50 mcg. FLONASE and NASONEX are approved for seasonal allergic and perennial allergic rhinitis in…
…total disclosure can determine potential bias and inappropriate influences. Presumably, this would incorporate the proposed Federal Sunshine Act. Second, the Baucus Plan seeks to create an independent private, non-profit entity…
…along with physical activity, may reduce the risk of osteoporosis later in life. FDA presents some sobering numbers in support of its effort. According to the final rule osteoporosis “affects…
…esters may reduce the risk of coronary heart disease and lower blood total and LDL cholesterol levels. The claims Wyeth makes for Centrum Cardio appear to substantially comply with FDA’s…
…the ruling cites a recent TTB determination that “a neutral malt beer containing malted barley at one percent of the total dry weight of all ingredients contributing fermentable extract to…
…a medical device). For a medical device subject to a Premarket Approval Application (“PMA”), the “testing phase” begins on “the date a clinical investigation on humans involving the device was…
On May 7, 2008, the U.S. Court of Appeals for the Federal Circuit is scheduled to hear oral argument in Lupin Ltd. v. Abbott Labs. This is a patent infringement…