We’re a little late to the party on this one (let’s just blame it on social distancing), but, after 10 years in the making, Transition Day has finally come and gone for protein products. For the uninitiated, on March 23, 2020, all products approved as …
A little more than ten years ago, on March 31, 2010, the Drug Enforcement Administration published its Interim Final Rule (IFR) with request for comments, titled “Electronic Prescriptions for Controlled Substances” (Docket No. DEA-218, RIN 1117-AA61). The rule became effective June 1, 2010, and is …
Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), manufacturers, distributors, and health care providers acting to address the COVID-19 crisis can be protected from products liability suits related to the use of certain products. The Act provides immunity “from suit and liability under …
While it seems like all of FDA is consumed with responding to the current COVID-19 crisis, the agency is still managing to continue its work in other areas. Earlier this week, FDA issued a final guidance, titled Nonbinding Feedback After Certain FDA Inspections of Device …
Last week FDA published a much needed guidance document addressing compounding by outsourcing facilities of shortage medications for patients confined to hospitals. Yesterday FDA took an unprecedented step (see Section 503A guidance) and recognized, during the COVID emergency (or until FDA withdraws the policy), Section …
Given the broad deference afforded to federal agencies, it is rare when a court overturns an agency action challenged under the Administrative Procedure Act (APA). In a recent decision, however, a court found that a regulation issued by the U.S. Department of Agriculture (USDA) violated …
FDA issued a much needed guidance document addressing compounding by outsourcing facilities for hospitalized patients during the COVID-19 emergency. Like its other recent guidance documents addressing the COVID-19 pandemic, this guidance sets forth FDA’s temporary policy — for compounding certain drug products for hospitalized patients …
In some news that is not about Emergency Use Authorizations, how to make a DIY face mask, or even about COVID-19, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published a final rule amending its regulations governing the labeling and advertising of wine, distilled …
During the COVID-19 pandemic, there is widespread agreement that one of the most important steps the government can take is to enable widespread testing of patients. Many experts have cited the lack of access to a sufficient number of tests as a fundamental flaw in …
From the enactment of the Medicaid Drug Rebate Statute in 1990 until last year, a term appearing in the statute – “original new drug application” – caused controversy and uncertainty. The term was not defined in the statute and the legislative history shone no light …
It’s no secret that FDA’s review and approval metrics are closely watched. In fact, these metrics are integral to evaluating whether FDA has met the commitment to industry it made during Prescription Drug User Fee Act (“PDUFA”) negotiations. As explained in our summary of the …
Amidst the onslaught of regulatory and legislative announcements and changes occurring daily during this unprecedented time, a long-awaited (in some quarters) legislative change quietly and finally became law. On March 27, 2020, President Trump signed into law the CARES Act which includes an array of …
State regulators across the healthcare professions continue to issue a number of guidances and waivers as part of the larger COVID-19 response. We have previously blogged on a number of waivers issued by state pharmacy regulators in connection with COVID-19 response related to pharmacy staffing …
As readers of this blog may recall, the Food Safety Inspection Service of the USDA (FSIS) received two Petitions regarding the Product of USA Labeling for Meat Products. (See here and here for our blog posts). In 2018, the Organization for Competitive Markets and the American …
In a March 13, 2020 opinion, the United States Court of Appeals for the District of Columbia Circuit handed Eagle Pharmaceuticals, Inc. (Eagle) a significant win in FDA’s appeal from a District Court order requiring FDA to grant Orphan Drug Exclusivity to Eagle’s Bendeka (bendamustine) …
