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Category Archives: Regulation

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European Medicines Agency’s new guide on the wording of therapeutic indication

1.            Introduction On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The therapeutic indication is the primary information concerning the use of a medicinal product. The guide provides that therapeutic indications should clearly state

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ability to integrate digital health tools which are regulated as medical devices.  The guidance describes when a Type V drug master file (DMF) can be used to

Poland: Implementation of the EU rules on falsified medicines

The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human

What the European Medicines Agency’s qualification opinion means for electronic clinical data capture

1.            Introduction The European Medicines Agency (EMA) issued a qualification opinion following a request concerning proprietary eSource DDC (Direct Data Capture) technology. This technology allows the capture of clinical study source data electronically by investigator site staff at the point of care. In its opinion, EMA’s Committee for Medicinal Products for Human Use (CHMP) does

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

1.            Introduction On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

1.            Introduction On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation

Publication of rules on designation of expert panels under the Medical Devices Regulations

1.            Introduction In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide

European Medicines Agency’s clarification regarding re-testing exemption for imported advanced therapy medicinal products

1.            Introduction On 21 August 2019, the European Medicines Agency (EMA) published questions and answers regarding imported advanced therapy medicinal products (ATMP). The document focuses on the possibility of batch controls exemption for ATMP imported into the European Union from a third country. It provides guidance concerning grant of the exemption, data to be submitted

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices. The Draft is to implement the requirements of Article 17(3) of the Medical Devices Regulation 2017/943 (hereafter “MDR”). Article 17 MDR provides that under certain conditions, health institutions can reprocess

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of developing a broad drug importation program. Instead, the working group’s remit was specifically limited to considering potential

Ill-Suited: Private Rights of Action and Privacy Claims

“For years, the plaintiffs’ bar has conjured multibillion-dollar class action lawsuits out of largely intangible privacy harms. This wave of litigation is increasingly driven by federal and state statutes that include private rights of action and allow for excessive statutory damages. Given the willingness of some courts to let cases proceed despite a lack of

The Court of Justice clarifies the EU customs rules applicable to customs valuation

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 agreements (“Judgment”). By way of background, in 2005, Oribalt Riga SIA (“Oribalt”) concluded a consignment agreement with Ranbaxy Laboratories Ltd. (“Ranbaxy”). Pursuant to this

FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid Inquiry Program (“TRIP”), which will assist human cell, tissue, and cellular and tissue product (HCT/P) manufacturers, as well as stakeholders that market HCT/Ps, to “obtain a rapid, preliminary, informal, non-binding assessment from

U.S. Supreme Court Sidesteps Important TCPA Deference Issues

On June 20, 2019, the Supreme Court released its long-awaited decision in PDR v. Carlton & Harris Chiropractic.  The Court was expected to provide greater clarity about the extent to which litigants can challenge the Federal Communications Commission’s (FCC) Telephone Consumer Protection Act (TCPA) interpretations in private litigation.  Instead of deciding that issue, however, the

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Agency seeks input on “comparative advantage” requirement for new opioids Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” outlining the benefit-risk framework the Agency intends to use in assessing whether a new opioid drug application meets the

The European Commission releases an updated Borderline Manual for medical devices

Introduction The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

FDA authority to crack down on illegally marketed stem cell treatments confirmed On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug Administration’s (FDA) motion for summary judgment, and stopping the clinic from offering its stem cell therapy to patients. The

FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request process for oncologists.  Under the new program, FDA staff will help guide physicians through the process of applying for expanded access by

NHTSA, FMCSA release advanced notices of proposed rulemaking regarding autonomous driving systems

The National Highway Traffic Safety Administration (NHTSA) and Federal Motor Carrier Safety Administration (FMCSA) today each issued an advanced notice of proposed rulemaking (ANPRM) regarding the removal of regulatory barriers to the safe introduction of automated driving systems (ADS) on public roads. I. NHTSA’s ANPRM NHTSA’s ANPRM focuses on how to amend its crash avoidance

Update on FCC 5.9 GHz band rule-making

On May 14, 2019, Federal Communications Commission (FCC) Chairman Ajit Pai announced plans to open a rule-making to take a “fresh look” at the 5850-5925 megahertz (MHz) (5.9 gigahertz (GHz)) spectrum band. Initial reports suggested that the FCC would take the issue up in June, but the 5.9 GHz rule-making was not included on the

FDA Chief of Staff: OTC reform remains “top priority” for FDA

Speaking Tuesday, May 21, at the Consumer Health Products Association Regulatory, Scientific, and Quality Conference, FDA Chief of Staff Lauren Silvis emphasized that over-the-counter (OTC) monograph reform remains a “top priority” for FDA.  Based on these comments, FDA is clearly not giving up on monograph reform: FDA has long engaged in this effort, and we will

FDA guidance may ease path to biosimilar interchangeability

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable with a reference product.  Even as some of the details remain to be hashed out, the guidance makes clear FDA’s desire to minimize the burdens of