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…MDCO’s alleged unclean hands before FDA and in filing the patent infringement lawsuits. According to APP, MDCO “comes to these lawsuits with unclean hands that preclude MedCo’s requested relief,” because…
…not claim either – (aa) the drug for which the application was approved; or (bb) an approved method of using the drug. The MMA also added an almost identical counterclaim…
…not withdrawn. Although Antares raised in its petition, among other things, choice of listed drug and pharmaceutical equivalence issues, all FDA needed to deny the petition was to answer one…
By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal…
…OZO, OZP, OZQ) Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC ) Automated external defibrillators (e.g., MKJ, NSA ) Duodenoscopes (on the reprocessing; e.g., FDT) with elevator…
…as the basis for general nutrition advice; however, individual calorie needs may vary.” The regulations would also require establishments to provide more detailed nutrition information upon customer request, including information…
…premarket submission may require animal or clinical studies, additional performance specifications, and other additional information to support clearance or approval, even if it conforms to relevant consensus standards. The new…
…of product applications, particularly for flavored e-cigarettes. “I believe certain flavors are one of the principal drivers of the youth appeal of these products,” said Dr. Gottlieb (in March 2018,…
…drive further innovation in response to real world performance and user feedback. Unlike most traditional medical device products, Digital Health has the potential to offer real-time learning through real world…
…24, 2018, FDA sent an official request for information to JUUL Labs, requesting the company submit information, such as documents related to product marketing; research on the health, toxicological, behavioral…
…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…
…to online summaries of two studies that pertain to prevention and treatment of macular degeneration: ‘Age-Related Eye Disease Study (AREDS), National Eye Institute, National Institutes of Health’ [and] ‘Age-Related Eye…
…and himself, Mr. Sasinowski offered four recommendations: Proposal #1: FDA should consider the appropriateness of the Accelerated Approval process for every new therapy. Proposal #2: FDA and sponsors should use intermediate clinical…
…between the parties. The OIG also determined that the arrangement does not have the potential to influence Medicare or Medicaid beneficiaries to use the online pharmacy for federally reimbursed products,…
By Riëtte van Laack – On April 9, 2015, FDA published a proposal to amend the regulations regarding registration of food facilities. The proposal addresses a multitude of issues: codification…