FDA has long said that it would consider real-world evidence (RWE) in making regulatory decisions related to medical devices. Those in industry know that FDA can be very critical of RWE, however, and it is not always clear why RWE was (or was not) acceptable …
Tooth whiteners – drugs or cosmetics or both? In the case of certain tooth whiteners, the regulatory status remains gray, apparently with no prospect of illumination from the Agency. As we reported back in 2014, FDA’s interest in the regulation of peroxide-containing tooth whiteners began in …
On March 24, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its first advisory opinion of the year. Advisory Opinion 21-01 addresses whether the provision of a specific drug at no cost by a pharmaceutical manufacturer to a …
For more than five years now, FDA has pursued action regarding cannabidiol (CBD) products. FDA has taken the position that CBD is not a lawful food or dietary ingredient. But despite the agency’s strong statement about CBD, FDA has acted, primarily through Warning Letters (WLs), …
On March 17, 2021, FDA granted BioFire Diagnostics’ De Novo, making it the first COVID assay originally authorized on a temporary basis for this public health emergency to be given permanent access to the US market. While FDA has only released the signed letter affirming …
Over the past several years, FDA has faced criticism stemming from high-profile device issues related to materials, including the Essure permanently implanted birth control device and metal-on-metal hip implants. Given this, it is not surprising that device biocompatibility has received greater focus in FDA premarket …
On August 25th, 2020 Hyman, Phelps & McNamara, P.C. released a blog post covering experiences and lessons learned from our interactions with FDA and what was at the time the new and unfamiliar EUA pathway (FDA, Testing, and COVID-19: A “Mid-Mortem”). In the six months …
The FDA is legally established as a law enforcement agency. But its structure and activities have also generated its own “branding” as a trusted independent validator of medical devices. This public trust gives FDA tremendous power. If a device has not undergone FDA’s premarket review (even …
On March 16th, 2021 CDRH announced a major policy change for the EUA program in an effort to expedite screening testing for the pandemic. Screening is the testing of asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make …
On Friday, March 12th FDA posted a letter to healthcare providers about performance concerns regarding the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza Test for use on cobas Liat System. This public letter appears to be the culmination of a dialogue between Roche and …
On February 17th, 2021 the Biden Administration announced an expansion of the Federal strategy to test the population for SARS-CoV-2 with a three pronged approach: Expand COVID-19 testing for schools and underserved populations ($650 Million); Ramp up the domestic manufacturing of testing supplies and raw materials ($815 …
Perhaps when you’re carving out a patented method of use? Well, at least that’s what GSK is arguing. As the now-infamous GSK v. Teva case makes its way through the Federal Circuit once again to address what many have called the death-knell to skinny-labeling (also …
The Senate recently reintroduced legislation that would promote research into medical use of marijuana. The legislation would also importantly correct a deficiency in prior law and the Drug Enforcement Administration’s (“DEA’s”) recent rulemaking related to synthetically derived CBD. Marijuana remains classified as a schedule I controlled …
Last Thursday March 11, the American Rescue Plan Act of 2021 was signed by President Biden. Out of the hundreds of pages of this COVID relief legislation, our pinpoint focus here is on several pages relating to Medicaid coverage and drug rebates. The legislation requires Medicaid …
I would be lying if I said I hadn’t expected this most recent OPDP Untitled letter. OK, maybe not THIS letter. Some background: Back in November 2020, after an article was published about the ethical questions surrounding “Sponcon,” (sponsored content – for those not hip …
