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…– OIG will review FDA’s oversight of drug manufacturers’ compliance with the requirement to electronically submit to FDA complete and accurate drug labels for currently marketed prescription drugs. In December…
…below. Those fluctuations are attributable to several factors, including the changing landscape of generic drug manufacturers: there were 258, 177, and 199 small size operations in FYs 2018, 2019, and…
…copies of insulin,” a commitment the Agency undertook under the watch of Commissioner Gottlieb and appears to be continuing under Acting Commissioner Giroir, FDA issued a draft guidance last week…
…if so, a description of the change or improvement. There is an exception for a generic drug that is manufactured by four or more companies and is either (1) marketed…
…acids” that is indicated for the treatment of relapsing forms of multiple sclerosis (MS). Two generic versions referencing Copaxone are on the market: one approved in 2015 and the other…
…of 60 days for non-complex questions and 120 days for complex questions. Theoretically, designation of RLDs and RSs should not be complex, but even if such requests are considered complex,…
…pharmaceutical companies and the lost savings from slowed generic and biosimilar market entry. As AAM explained, AB 824 will lead—and has already led—to delays in availability of generic medicines and…
…requirements for drug-device combination patents are not clear. However, commenters all had different perspectives about the best way to address these patents. One commenter, for example, suggested that any component…
…provisions that would apply for the first time to old antibiotics (i.e., those provisions that comprise the generic drug approval program first enacted in 1984). The term “Drug Price Competition…
…effectively preventing the parties from settling, it is likely that this bill will discourage generic drug companies from bringing challenges to brand companies’ patents in the first place—and as a…
…and recently stated that such agreements are “presumptively illegal” (see our recent post here). FTC Chairman Jon Liebowitz commended the House Energy and Commerce Committee for adopting the Rush Amendment. …
…best communicate those suggestions to the generic drug industry. Specifically, FDA is seeking comment “about any difficulties sponsors are having developing and preparing their ANDA submissions that FDA could help…
…the following (page numbers refer to the Committee’s Modifications list): In one of three amendments favorable to generic drugs, the Medicaid Federal Upper Limit (FUL) provision of the Mark, which…
…to the bioequivalence of [the generic].” The generic defendant moved to dismiss. The court characterized the defendant’s argument as follows: Defendant, in its motion to dismiss, claims that the Food…
…mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg. It looks like it may not be much of an Independence Day Holiday for some of FDA’s attorneys….