Animals, shmanimals. Or so says FDA. Well, FDA didn’t actually say that, but that’s the effect of the District Court of D.C.’s recent ruling in Vanda Pharmaceuticals v. FDA. In a case we have been following for the last year or so, the District Court …
The FDA is taking very seriously the threat of the coronavirus from China (2019‑nCoV). Makers of medical devices, drugs and biologics should consider whether their products can contribute to countering this threat. In late January, FDA announced its strategy to advance development of medical countermeasures to …
Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with …
Too often, children are not included in clinical trials for new drugs, even though children may eventually be prescribed those very same drugs. This forces physicians who treat children to try and extrapolate information collected from adult trials to determine if and how to use …
On December 13, 2019, Nature Reviews Drug Discovery published an article that reviews the landscape of the development of drugs for rare diseases, both the progress and challenges. The article was authored by HP&M Attorney James E. Valentine along with co-authors from the BioPontis Alliance …
On November 13, 2019, the National Academies of Sciences, Engineering, and Medicine (NASEM) Forum on Regenerative Medicine hosted a workshop on Exploring Novel Clinical Trial Designs for Gene-Based Therapies. The Forum was tasked with exploring the design complexities and ethical issues associated with gene- and …
On November 7, 2019, gene therapy company Regenxbio Inc., filed suit in U.S. District Court in Washington, D.C. against FDA asking the court to set aside a partial clinical hold on one clinical trial and a full clinical trial for another. The complaint also seeks …
Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …
FDA recently finalized a Guidance for Industry to help guide the development of new products for patients with amyotrophic lateral sclerosis (ALS). The original draft guidance was published early in 2018 (see our previous post here). ALS, colloquially known as Lou Gehrig’s Disease (ALS forced the …
On October 1, 2019, FDA issued its second Patient-Focused Drug Development (PFDD) draft guidance – the next in a series of four methodological guidance documents, which discuss the collection of patient experience data to support decision-making related to drug development and approval (see some of …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 34th iteration – is scheduled to take place from September 18-19, 2019 at The Bostonian Hotel, Boston, MA. The conference is billed as the premier event to provide folks with a roadmap …
Last week, Global Genes, a global rare disease patient advocacy organization, announced the 2019 RARE Champion of Hope Awardees, which included Hyman, Phelps & McNamara, P.C.’s very own, James Valentine. This is a great honor, bestowed upon “true champions for rare disease”, “people who inspire …
On May 24, 2019, FDA approved Avexis’s BLA for its gene therapy, Zolgensma (onasemnogene abeparvovec-xioi), for treatment of spinal muscular atrophy (SMA). This represents the first approval of a systemically-administered somatic gene replacement therapy. (The first gene therapy approved by FDA was Luxturna in Dec. …
