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…FDA’s recent review of the overall 510(k) process. In light of criticisms from lawmakers and the trade press about the Menaflex clearance process, in April 2009 FDA Principal Deputy Commissioner…
By Ricardo Carvajal – Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. (“PAO”), a…
…annual report confirms what was becoming apparent at the 7-month mark – foodborne pathogens (especially Salmonella) and undeclared allergens/intolerances are the principal culprits, together accounting for more than 85% of…
…Patient Protection and Affordable Care Act. Hyman, Phelps & McNamara, P.C. has prepared a summary of the proposed rule, which is available here. The CMS proposal is unusual in the…
…or manufacturing technologies) on safety and regulatory status. FDA cites both of the above guidance documents in its partial denial of a citizen petition submitted by the International Center for…
…major food allergens.” Undeclared major food allergens continue to be one of the two principal causes of reportable food incidents, typically leading to Class I recalls. As acknowledged in the…
…of the submitted information. In this educational session, Dara Katcher Levy, alongside Jonathan Toft, PharmD, MBA, Principal at Formulary and Rebate Optimization, MedImpact Healthcare Systems, Inc., will delve into the…
By Ricardo Carvajal – FDA announced that it executed a Food Safety Systems Recognition Arrangement (“RA”) with its counterpart in New Zealand, the Ministry for Primary Indsutries (“PMI”). The RA…
…a misdemeanor. However, their principal argument on appeal was that their convictions were not “relating to fraud.” Remember that they had pleaded guilty to a misdemeanor offense under the FDC…
…Oral Solution was administered “due to the visual similarity of the container labels and carton labeling of the two product strengths.” As to the legal status of unapproved single-ingredient, immediate-release…
…USP Expert Panel on Food Ingredient Intentional Adulterants defines intentional or economically motivated adulteration as “the fraudulent addition of nonauthentic substances or removal or replacement of authentic substances without the…
…must now be registered at ClinicalTrials.gov. Second, certain results information from applicable clinical trials must now be submitted to the clinical trial registry data bank. An “applicable drug clinical trial”…
…American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance – see our previous post here. …
…came out in support of federal legislation to “end the practice of pay for delay in prescription medicine.” Knowledge Ecology International (“KEI”). KEI, which is an international non-profit, non-governmental organization…
Genetics and genomics are becoming crucial to clinical care. As the “precision medicine” revolution spreads, cancer treatment, rare disease diagnosis, and cardiac care increasingly utilize genomics. Unfortunately, law and policy…