…raised by sponsors about FDA’s review and approval process for medical products, particularly medical devices.  Though the bill applies generally to all medical products, many of the provisions relate specifically…

…obtained a consent decree entered against Baxter forbidding further manufacture of the Colleague infusion pumps.  The consent decree also required Baxter to submit a corrective action plan within 20 days…

…for notification in the pharmaceutical context can be found here. They will likely apply in the biologic context as well. Although the market for biosimilars is not yet competitive enough…

…Section 804 of the Federal Food, Drug, and Cosmetic Act (FDC Act), 21 U.S.C. § 384, allows HHS to promulgate regulations that allow for the importation of certain FDA-approved prescription…

…justify the potential risks, and the requested use will not interfere with clinical investigations that could support marketing approval. The primary purpose of providing individual access to an investigational drug…

On April 26, 2019, CDRH released the final guidance, Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions (“Final Guidance”). We previously blogged on the draft…

…can be reduced if natural history studies are similar to the clinical trial in the following ways: Assessment/measurement of critical patient disease characteristics; Aspects of standard of care of the…

…HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets can be summed up in two (Latin) words: Caveat Utilitor (That is, let the user beware).  The cautionary note is…

…for purposes of determining the income eligibility of such individual for medical assistance under the State plan or any waiver of such plan.” Because, according to Sen. Wyden, there are…

…National Drug Control Policy.  The report will require feedback from patient groups, pharmacies, drug manufacturers, common and contract carriers, hospitals, state attorneys general, law enforcement, insurance providers, and drug distributors. …

…benefit veterans, address the prescription drug abuse crisis, secure access to medical care, and improve certain provisions of the Controlled Substances Act.  Several witnesses testified in support of the bills. …

…context of medical device software, FDA states that it will apply the same principles to traditional devices as well. A Future Regulatory Paradigm with Potential Broader Implications (May 29, 2018)…

…of FDA’s June 2017 Orphan Drug Modernization Plan designed to eliminate the designation application backlog. As part of the plan, FDA introduced collaboration between different review divisions, reduced other regulatory…

…on the small molecule side. The proposed technical correction regulation, the other two guidance documents, and the list deal with the transition of certain biological products from NDAs to BLAs….

…traditional small molecule generic market. With resource-rich companies acting as both reference product and biosimilar sponsors, the game can be played a little differently. Indeed, Pfizer has approval for two…