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Earlier this week, FDA published another in its series of guidance documents devoted to implementing the Biologics Price Competition and Innovation Act (“BPCIA”). The objective of the new guidance, entitled…
…federal common law of unfair competition. For starters, Amarin alleges that distributors of the identified Synthetically Produced Omega-3 Products are making literally false statements about their products insofar as their…
…start, clearly define the expectations, roles, and responsibilities of all partners, including the resources being committed, data being shared, and objectives of the program Build the trust required for successful…
…Senate Committee on Health, Education, Labor, and Pensions, the GAO: (1) examines how user fees supported FDA’s generic drug program; (2) describes FDA’s improvements to the generic drug application review…
…practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by…
…37th [2017] edition of the Orange Book): Consistent with the definition of strength included in Section 1.2,Therapeutic Equivalence-Related Terms, the strength of parenteral drug products generally is identified by both…
…Black Hole.” Another company referred to it as the “Endless Summer,” because that company has been trying to figure out when their compliance status will change in the FDA computers…
…that comply with FDA GMPs (other than controlled substances, inhaled drugs for surgery, and compounded drugs) to be imported foreign wholesale distributors or licensed pharmacy operators certified by FDA to…
…permitting the sponsor to bring legal action for failure to comply does not indicate that the compliance with the statute is optional. This interpretation is consistent with the statutory purpose…
…us) made inquiry at a high level within the General Accountability Office (GAO) and learned that FDA did comply with the Congressional Review Act. Unfortunately, the GAO database has not…
DEA’s administrative docket is off to a quiet start this year. Since January, the Administrator has issued five final orders, all of which are so-called “loss of state authority” cases….
…guidance on use of bulk substances in compounding has had a slow start, in part because of “over nominations” in early 2014 and general confusion in the nomination process (see…
Change is inevitable (cue David Bowie’s “Changes”). Sometimes change occurs slowly and goes (largely) unnoticed, and sometimes it comes fast and unexpected. Sometimes change is good, and sometimes it’s not….
…any such efforts were undertaken by Hampton Creek, they appear to have been unsuccessful in warding off FDA’s warning letter. The focus now shifts to whether the company can devise…
…and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken…