Menu
Your search for “Cotizar seguro de autos Winchester NV llama ahora al 888-430-8975 Seguro total para autos Caja de ahorro seguros automotor Companias de seguros baratas Seguros de coche precios Nombres de seguros de coche Cotizar poliza de seguro” returned the following results.
…indication: “for treatment of pediatric patients 7 to 17 years of age with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, nonHDL-C and ApoB as an adjunct to diet,…
By Jenifer R. Stach & Ricardo Carvajal – Carrying through on what had been designated as a high priority item, FDA rolled out its sodium reduction initiative with several actions, all…
…include all relevant information and documentation to support the WAC increase, which may include: all factors that have contributed to the WAC increase; the percentage of the total WAC increase…
…determination, FDA may consider only information and data that are based on “relevant and reliable scientific principles and methodologies”. A hearing for a final order is not a formal, trial-type,…
…regard to whether both the initial brand name drug and the line extension must be an oral solid dosage form, the Court found that CMS’ interpretation that only the initial…
…including any artificial flavor, artificial color, synthetic version of a naturally occurring substance, or any ingredient “that has undergone chemical changes” (but not including food that has undergone a traditional…
…suppression or total prohibition of potentially misleading speech where an alternative non-misleading presentation, possibly disclaimers, may be available. POM also argues that the order violates the Administrative Procedure Act (“APA”) …
…New Approach Methodologies (methods to be used in place of traditional animal testing). The sponsor needs to have selected a specific investigational product or have a product-derivation strategy to evaluate…
…[state or local] requirements relating to the sale [or] distribution…of tobacco products.” In finding no conflict between local and federal law, the Court held that “at most, the City Ordinance…
By Ricardo Carvajal – FDA denied a citizen petition filed on behalf of OVOS Natural Health, Inc. (“OVOS”) that asked the agency to issue a regulation under FDC Act §…
…to grow unabated in 2010, for a grand total of 2,361 original ANDAs pending at the close of 2010, and with an estimated median approval time of 31 months. (According…
…1963 original applications and ended the year up almost 400 applications, for a grand total of 2361 pending original ANDAs. The backlog has, not surprisingly, affected median ANDA approval times. …
…record 323 orphan drug designation requests come through the door and granted 192 designations (for a grand total of 2308). Despite the intense interest in orphan drugs, however, FDA approved…
…an unknown period of delay of FDA review and approval that could stretch far beyond the 12-year total that was set in the legislation,” says the letter. “We concur with…
…to expire.” The statute provides that a total of 5 interim PTEs may be granted. After the initial interim PTE is granted, 35 U.S.C. § 156(d)(5)(C) provides that “[e]ach such…