The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is transferred from the clinical trial sites (hospitals/HCPs) to the sponsor (i.e. pharma or device company) is transmitted in electronic form.
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance or approval from the agency prior to marketing.
An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK. The mCTA is a standard form contract which is intended to be used by clinical trial sponsors and NHS/HSC organisations without modification. Previously, under
The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of the dossier. Background The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely
The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws, state-level legislation has paved the way for a new law at the federal level to expand access to these investigational medicines.
FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7.
On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. The document supplements the EU Delegated Regulation adopted in 2017 setting out GMP obligations for investigational medicinal products. The Delegated Regulation establishes a pharmaceutical
The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in innovative ways.
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”).
Yesterday, FDA published a January 3, 2018 Warning Letter issued to American CryoStem for marketing Atcell—an adipose tissue derived stem cell product—without FDA approval and for several drug current Good Manufacturing Practice (GMP) violations observed during FDA’s July 2017 inspection of American CryoStem’s New Jersey facility. In a related press release, the agency cited the
The European Medicines Agency has published a Practical Guidance concerning the steps that centralised Market Authorisation Holders will be required to take before Brexit.
The European Medicines Agency has published a checklist for applicants seeking qualification of novel methodologies.
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the future (so-called advanced decision, sometimes also referred to as living will, and translated as “Biotestamento” in Italian ). Advanced decision of
Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive scheme. Although no definitions in respect of these prohibited activities have been included in the Medicines Act, considerable guidance as to
Today, the President signed new legislation that gives the Department of Defense (DoD) new opportunities to advocate to FDA for expedited development, review, and Emergency Use Authorization (EUA) for medical products that could help protect and treat U.S. military forces. The legislation was developed as an alternative to a provision in the National Defense Authorization
The European Medicines Agency has published a guidance document for assessors written in questions-and-answers. It should be read in combination with the explanatory note to GVP module VII.
The European Medicines Agency has launched a new and improved version of EudraVigilance with several significant benefits.
The UK government has published a White Paper setting out its new Industrial Strategy and, as part of that strategy, has agreed a Sector Deal with the UK life sciences sector. The White Paper covers all industries and identifies the life sciences sector as having particular strategic value in the UK, generating £64 billion of
On November 16, in the context of announcing a comprehensive regenerative medicine policy framework (discussed here), FDA released a draft guidance document that describes the expedited programs available for the development and review of certain regenerative medicine therapies. Importantly, the draft guidance clarifies certain aspects of the Regenerative Medicine Advanced Therapy (RMAT) designation established by
Yesterday, the U.S. Food and Drug Administration (FDA) announced a comprehensive framework for development and oversight of regenerative medicine products, including innovative cell-based therapies. This initiative builds on the agency’s existing framework to set forth more clearly which products are subject to regulatory enforcement. In September, as we previously discussed here and here, FDA’s Commissioner,
Fast track for orphan diseases and rare forms of cancers By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new rules on expanded access to medicinal products, for which the authorisation procedure is still on-going, replacing the former Ministerial
Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately.
Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period.
On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly Information sheet on the FTP.