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…2008, the Food, Conservation and Energy Act of 2008 (2008 Farm Bill) amended the Agricultural Marketing Act of 1946 to impose COOL requirements on retailers for certain commodities. Covered commodities…
…the question of whether dietary compliance, and therefore patient health, will benefit from a medical food should be left to the medical community, not to FDA. Indeed, this approach amounts…
…compelled commercial speech. This type of speech is not subject to the strict scrutiny standard. In fact, “when the compelled speech is commercial and purely factual in nature, the speaker’s…
…Appellants further argue that AMS’s elimination of the allowance for commingling muscle cuts from different countries in the COOL regulation is outside AMS’s jurisdiction. (Commingling occurs when a processor processes…
…celebrate each year,” said ABA Journal Editor and Publisher Allen Pusey. And with respect to the FDA Law Blog, one reader’s comment was singled out as to why we won…
…May 2013 (see our previous post here). USDA gave industry until November 2013 to comply. The American Meat Institute (“AMI”) and others filed a complaint and request for preliminary…
…requiring more precise information on the location of each production step, and eliminating the option of labeling commingled animals. Previously, the lower court and the Court of Appeals panel found…
…70% increase in submission volume in FY2020, 35% in FY2021, and 20% in FY2022 as compared to FY2019. The FY2022 data is through October 17, 2022 and includes more than…
By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had…
…a well-controlled and consistent manner; and (iii) that data comparing European Union (EU)-approved Remicade EU)-approved to Inflectra could be used to show biosimilarity to US-licensed Remicade. A single dose PK…
…the provision deeming drugs adulterated based on an owner or operator limiting or refusing inspection, 21 U.S.C. § 351(j), and tersely identified three ways in which the company violated this…
…2016, FDA issued a request for comments regarding the establishment of duration of medically important antimicrobial drugs that currently do not have a duration limitation. The comment period closed March…
In late June, Pacira Pharmaceuticals informed the FDA, the European Medicines Agency, and Health Canada that the company had filed a notice with the U.S. Securities and Exchange Commission, advising…
We need to talk about nitrosamines. Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here…
…come off the market. Phibro holds the three NADAs at issue here, and the company, unsurprisingly, vehemently disagrees with FDA. In its whopping 70-page complaint. Phibro is asking for judicial…