The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
Multiple regulatory agencies continue to do their part in the fight against COVID-19. This week, the U.S. Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) and state boards of pharmacy all acted to...more
Shortages of gloves, gowns, face masks, respirators, ventilators, drugs and hand sanitizer continue to be reported. The crackdowns on prescribing of chloroquine and hydroxychloroquine, currently being studied to treat...more
In response to the COVID-19 outbreak in the United States, the Food and Drug Administration (FDA) has issued an increasing number of EUAs, now in the double digits, for in vitro diagnostic (IVD) products and personal...more
The U.S. now has the most confirmed coronavirus cases in the world, and the FDA and state boards of pharmacy are issuing daily guidance on how to stop the spread or join in the fight through relaxed standards or expedited...more
3/30/2020
/ Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Manufacturers ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Pharmacies ,
Restaurant Industry ,
Veterinarians
Hand sanitizer, critical infrastructure, drug shortages and Emergency Use Authorizations (EUAs) are the FDA updates on COVID-19 over the weekend....more
The Food and Drug Administration (FDA) and the state boards of pharmacy continue to issue guidance and policy daily. Now, the Drug Enforcement Administration (DEA) has joined in to provide guidance to industry and healthcare...more
Here, we provide you with the first update to important actions in the life sciences sector that the Food and Drug Administration (FDA) and state boards of pharmacy are taking to address the pandemic so far. ...more
The new coronavirus continues to be the leading global news headline. We have established a comprehensive online resource center to help address and answer legal questions about coronavirus disease 2019 (COVID-19). ...more
With just days remaining until the “Deemed to Be a License” transition takes effect, the FDA issued an unexpected sweeping change to compounding practice. ...more
It seems like CBD oil is all we talk about, but honestly, it’s almost all that our clients are talking about. If your marketing folks haven’t come to you yet with an idea to add CBD oil to something, they will almost...more
Departing Food and Drug Administration (FDA) Commissioner Gottlieb reiterated many of the things we have blogged about here recently in his testimony before a Senate subcommittee this past Thursday....more
There are both positive and negative developments regarding the likelihood of widespread legal sales of CBD oil products. Last week, a major retailer announced that it will begin selling cannabidiol (CBD) creams and salves...more
Senate Democrats recently introduced the Stop Price Gouging Act (S. 378), which seeks to place an excise tax on pharmaceutical companies in proportion to price spikes on prescription drugs.
The bill generally requires a...more
Last week Health and Human Services (HHS) released its Statement of Regulatory Priorities for Fiscal Year 2019. Several of the FY19 priorities include: (1) combatting the opioid crisis; (2) strengthening individual health...more
On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction...more
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With increasing healthcare costs and the transition to value-based reimbursement, never has the need for connected medical devices been so great – and never have the...more
There’s been a sea change in the political climate. The regulatory forecast is still uncertain, and pharmaceutical evolution continues to develop....more
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents and a memorandum related to off-label communications and the FDA’s power to regulate such communications. The publications are the...more
FDA had a busy holiday season, issuing two final guidance documents and two draft guidance documents for industry related to human drug compounding right before the start of the new year. These guidance documents cover...more
In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House...more
We may soon see a provision in the 2015 final rule addressing the utilization of end-stage renal disease related drugs and biologics come into action in the next few months. Specifically, the oral-only drug Sensipar may...more
Vermont recently became the first state to require drug manufacturers to provide justification for price increases. Under the new law, data on the cost of the drug will come from the state Medicaid program. The Department of...more
The U.S. Department of Health and Human Services (HHS) is reopening the comment period for the proposed rule titled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” HHS released...more
Recent activity by the federal government along with commercial payors may be indicative of further changes to how payors, providers, and pharmaceutical manufacturers engage in prescription drug arrangements.
A recently...more