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…or because of complaints or corrective actions, FDA would generally consider the removal of the indications for use to be a ‘major change’ that requires a new 510(k).” Yes, you…
…who may lose their exclusivity rights in the interim. (See prior posts here and here, and a challenge to FDA’s position on the start of the exclusivity clock here.) Other…
…List has not yet been updated to reflect receipt (i.e., filing) of an ANDA for generic SAMSCA containing a Paragraph IV certification. But Otsuka recently filed a Complaint in the…
…laboratory developed tests (LDTs). FDA’s proposed framework has sparked much controversy, receiving support from diagnostic test manufacturers and some patient groups, while other patient groups and the laboratory community have…
…onset of the compliance deadline of August 5, FDA issued reminders in the form of a Constituent Update and a blog posting by Deputy Commissioner for Foods and Veterinary Medicine…
…to reconsider its decision on the alleged rule change and reinstitute the “customary public hearing and comment process.” The OFPA creates standards for organic certification and establishes the National Organic Standards…
…a reverse incentive? That is, with the possibility of added exclusivity, is there an incentive for companies to start at the bottom and work their way to the top, obtaining…
…relapsed chronic lymphocytic leukemia, in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities). In September 2014—nearly ten years ago!—PTE applications…
…Notification of Commercial Marketing – Under FDA’s proposal, an ANDA applicant’s failure to timely notify the Agency about the date of commercial marketing (and thus the trigger for the start…
…provide for substantial NIH and FDA funding, estimated at $6B per year. But that funding is provided via a novel mechanism – drug companies that market blockbuster drugs and enter…
…hold otherwise,” wrote Disctirc Court Judge Rodney Gilstrap, “would invite generic manufacturers to submit incomplete or otherwise deficient applications, in order to secure their position as the first-filed generic. They…
…wholesalers should be warned that there is less flexibility in an important deadline for the “pedigree nouveau” that must be distributed with each package of prescription drugs. You must start…
…better guidance to applicants on how these physical attributes should be controlled and compared to the RLD. The issue of generic drug physical attributes and how they compare to their…
…is comprised of only legally marketed components (e.g., no RUO or IUO components), and whether the LDT is interpreted by a qualified healthcare professional, without use of software or automated…
…outbreak has begun winding its way through courts in multiple states, and early decisions in those cases suggest that food companies may want to start giving careful consideration to their…