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…XR, (iii) engaging in serial sham litigation to block and delay multiple generic companies, (iv) entering into a horizontal market allocation and price-fixing agreement with generic manufacturer Teva, and (v)…
…different flavors, varieties or combinations. As amended, the FDC Act would allow presentation of nutritional information for such products in ranges, averages, individual labeling of flavors or components, labeling of…
…pending final disposition of forfeiture proceedings would cause substantial hardship to the claimant, such as preventing ongoing business, preventing an individual from working or leaving an individual homeless; (4) the…
…of the hospital or medical office setting. In 2008, Massachusetts enacted a law that imposes compliance and reporting requirements on pharmaceutical and medical device companies that employ a person to…
By Ricardo Carvajal — FDA’s second annual reportable food registry (RFR) report confirms that foodborne pathogens and undeclared allergens continue to account for the vast majority of instances of reportable food. …
…Program for Fiscal Years 2006 through 2008. DEA noted that total obligations for the Diversion Control Program increased by 49 percent from Fiscal Year 2007 to Fiscal Year 2010. DEA…
…food can glean that information from the nutritional facts box, which is required to declare “sugars” per serving. Furthermore, it is information on total sugars, not just “added sugars” that…
…(identical, related, or similar, see 21 C.F.R. § 310.6(b)(1)) products that entered the market without FDA approval, for a total of 581 DESI reviews covering about 18,400 drugs. Although FDA…
…the fiscal year-over-fiscal year “potential pay-for-delay” deal numbers, you compare the “potential pay-for-delay” deals as a percentage of the overall final settlement agreements for each fiscal year, then there is…
…beginning 6 months, and ending 15 days before such term is due to expire.” The statute provides that a total of 5 interim PTEs may be granted. After the initial…
By Ricardo Carvajal – The New England Journal of Medicine published two articles bound to stoke more controversy in the battle over approaches to countering obesity. A perspective piece authored…
By Riëtte van Laack – Although there are currently no federal standards governing the labeling of organic cosmetics, cosmetic products sold in California are subject to the California Organic Products…
…note transaction and that her total earnings amounted to over $134,000. However, according to the complaint, Kellogg actually made $50,000 less than what she claimed. The complaint also alleged that…
…exclusivity also extends by six months the 7-year period of orphan drug exclusivity applicable to a biological product. For both drug and biological products, the law contains a similar exception…
…Memorandum for All United States Attorneys (Aug. 29, 2013), 3. (Attorney General Jeff Sessions rescinded the Cole Memorandum and all prior DOJ guidance on marijuana enforcement in January 2018.) Earlier…