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Your search for “♊ близнецы гороскоп на сегодня ❰близнецы гороскоп на сегодня❱♊-bit.ly/Gemini-serodnya” returned the following results.
…missing data, many physicians were unable to confirm the accuracy of the data reportedly associated with their practice. The American Medical Association (“AMA”) stated that “[o]nly 26,000 physicians out of…
…prior to that was only accepting pre‑submissions for COVID-related tests. This update will likely come as a relief to many in the in vitro diagnostic space that have been wanting…
…definition of a “device mode of action,” which currently reiterates the statutory definition of device, but as revised would simply reference that definition. Interestingly, in describing the benefits of the…
…drug designations. Those numbers are a bit off the previous records of 582 and 526 orphan drug designation requests in 2016 and 2017, respectively, and 477 orphan drug designations in…
…to address very important considerations with respect to generic competition. As we recently discussed (in an only tangentially related blog post), only patents listed in the Orange Book are eligible…
…regulation, we scoffed at it a bit. Would FDA really carry through with this threat? After all, the regulation right below it—“(3) If FDA concludes that a first applicant is…
…used in an aircraft, sponsors will need to make sure labeling covers this issue. Submitters should be sure to review all questions of the template carefully early in development to…
…Letter Decision. As the L-valyl ester of ganciclovir, valganciclovir HCl (VALCYTE) is actually a prodrug for ganciclovir. After oral administration, valganciclovir is rapidly converted to ganciclovir by intestinal and hepatic…
…(usually hourly) basis. So we replaced the old 2011 CFR set with the new 2012 set. Lo and behold, one bookend moved to the right quite a bit to accommodate…
…drug exclusivity for GRALISE (gabapentin) Tablets, the court (Judge Ketanji Brown Jackson) has finally ruled in the case. And it’s a bit of a shocker! In an Order handed down…
…Book (and just as much information, though organized a bit differently, in the electronic and app versions of the publication). But, despite all of that information, the Orange Book has…
…approved on July 16, 2012), may finally be at an end (pardon the pun). Last week, the U. S. District Court of the District of Columbia issued a Memorandum Opinion…
…market. And FDA decided to ring in the new year a bit early. Two of the BAP guidance documents recently released focus specifically on scientific and regulatory considerations for the…
…especially if a given generic product is expensive to produce (i.e., more complex products). A market exodus could disrupt the generic supply and ultimately lead to drug shortages. Alternatively, with…
…differently. See what you’re missing without the suffix: http://bit.ly/2G2zGTa.” A patient brochure stating that a “biosimilar is not approved as interchangeable . . . ” and “switching or alternating back…