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Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
In June 2021, Philips notified the ANSM of a field safety action that related to the potential risk of degradation and inhalation of carcinogenic compounds from the sound-absorbing foam used in its ventilation devices for...more
On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
Companies often come to us when they feel that they are ready to submit their medical device to the FDA for clearance or approval, but Medical Technology newcomers may not realize the amount of time and effort that truly goes...more
On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices, titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket...more
At the April 13, 2022 Georgia Board of Pharmacy meeting, the Board discussed changes to Chapter 480-36 which governs retail pharmacy remote drug order processing. The discussion was aimed at new verbiage that would require...more
In 1964, Sam Cooke sang “A Change is Gonna Come.” In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its Code of Ethics on Interactions with Health Care Professionals (the...more
At the March 30, 2022 Kentucky Board of Pharmacy meeting, the Regulation Committee reported on its March 15 meeting where it discussed the new proposed non-resident pharmacy permit regulation. The Committee requested...more
The U.S. Food and Drug Administration (FDA) published on February 23rd, 2022, a rule proposal to overhaul medical device quality control regulation. According to the FDA, the proposed rule change would “amend the device...more
In a nod to Alice Cooper’s 2000 song, “It’s the Little Things” (or, for literary fans, Robert Frost’s quote, “It’s the little details that are vital; little things make big things bigger”), the Food and Drug Administration’s...more
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more
The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more
Among the most active markets in private equity, the healthcare industry is ripe with opportunity for players in the healthcare services arena that can navigate the fast-paced deal environment and complex regulatory...more
McDermott’s annual European Healthcare Private Equity Leadership Forum is a must-attend event for executives from top management teams, health and life sciences companies and providers, private equity, family offices,...more
The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more
On 1 March 2019, the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the...more
On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more
In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical...more
Federal False Claims Act (FCA) recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years. Healthcare cases,...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more