Menu
Your search for “Cotizar seguro Menifee CA llama ahora al 888-430-8975 Seguro coche nuevo Cia de seguros principal Seguros para vehiculos precios Valor seguro vehiculo Asegurar mi auto online Cuanto cuesta un seguro de auto” returned the following results.
…not withdrawn.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…
…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…
…served as flypaper for Paragraph IV patent certifications from several ANDA sponsors, including APP Pharmaceuticals, LLC (“APP”), the company embroiled in a battle with MDCO in the Federal Circuit over…
…automatic construction and auto-filling content; content and structure that is complementary to CDRH internal review templates; integration with FDA databases and guidance documents; and automatic verification. While eSubmitter is a…
…process.) eSTAR submissions are automated (e.g., form construction, auto filling). eSTAR will prompt for attachments when necessary; this includes financial certifications and disclosure statements for the section of clinical testing….
…just an individual patient. For example, the Maryland standing order allows all Maryland licensed pharmacists to dispense naloxone, including any necessary supplies for administration (e.g., syringes), to any individual without…
…requests in an eCopy format. The eSTAR templates can also be used to respond to requests for additional information. When entering the template, the user can select “additional information” as…
…the principal investigator of such clinical trial if designated by a sponsor, so long as the principal investigator is responsible for conducting the trial, has access to and control over…
…and safety. The agency can also be expected to take action against products found to be contaminated with microbiological or chemical substances that pose a hazard to health. With respect…
…the drug product is not subject to the statute’s approval requirements. According to the National Drug Code Directory, Lannett has marketed four Cocaine HCl Topical Solution drug products without approval…
…decisions in this area on a case-by-case basis and will look for “measurable effects,” typically demonstrated by data from clinical or preclinical studies and bioassays, and possibly including evidence that…
…coverage of “usual patient care” in qualified clinical research. “Usual patient care” is defined as routine clinical services and investigational clinical services in clinical research when the investigational clinical services…
…R. Lenz, a highly esteemed Principal Medical Device Regulatory Expert at HPM will lead the session. Ms. Lenz brings a wealth of experience, having provided consulting to medical device and…
By Carrie S. Martin – On April 29, 2009, FDA issued a final rule requiring new labeling for over-the-counter (“OTC”) pain relievers and fever reducers, also known as internal analgesic,…
…study site locations, and results. The “responsible party” is the sponsor or principal investigator of the trial. An “applicable clinical trial” is generally defined to mean any clinical trial (other…