…viewed as manufacturers and points to its own webpage for support. This comparison is misplaced. Unlike hospital reprocessing facilities, many clinical laboratories are overseen by laboratory directors who themselves are…

…that simply means that not all drugs can be devices. According to FDA, it does not prevent all devices from being drugs. When it comes to devices, FDA says, the…

…systems for medical devices (under the Medical Device User Fee and Modernization Act of 2002) and animal drugs (under the Animal Drug User Fee Act of 2003).  FDA has also…

…which drugs or biological products are added, is “of potential significance to the development of functional food ingredients.”  Further analysis convinces us that FDAAA § 912 could represent a fundamental…

…be masquerading promotional material as “disease-state” information via websites with unbranded web addresses.  Companies, therefore, should be wary of registering websites for any third parties with which they would like…

…all through page 150, line 16.”  Those line references are to entire Section 37 of the House-passed H.R. 1249, which states: SEC. 37. CALCULATION OF 60-DAY PERIOD FOR APPLICATION OF…

…14) 340B sales and best price: All prices to 340B covered entities are excluded from best price, not just “prices charged under the 340B program,” as proposed. (P. 15) “Original…

…filed by Bayer and several generic drug defendants.  The Court’s decision, which came out within a week of the Federal Trade Commission’s (“FTC’s”) Fiscal Year 2011 report on patent settlement…

…sufficient; similarly, some argued that immunogenicity in product switches must be robustly assessed while others contend that immunogenicity is a “hypothetical concern”. Comments also provided line-by-line analyses of the text,…

…After dispensing with a jurisdictional dispute raised by Allergan that the Federal Circuit does not have jurisdirction over the appeal, the Court went on to address Athena’s appeal of the…

…a week ago, two days after the statutory deadline, CFS (together with the Center for Environmental Health) has again sued AMS. This most recent suit alleges that AMS has unreasonably…

…we see several analyses of the effects of citizen petitions on generic competition, as well as recommendations to improve the petitioning process (see here, here, here, and here). Another annual…

…and place all food safety responsibilities in a single federal agency, announced on September 28th that he would propose an amendment to sunset all food safety agencies by 2010.  Sen….

…to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability under the act if the additional statement is unsubstantiated…

By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. (“Matrixx”)…