On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated instructions for use and reprocessing instructions addressing cleaning, disinfection, and sterilization.
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674 certifications stating that they have complied with their obligations to submit required clinical trial information to clinicaltrials.gov.
The Court of Justice of the European Union (“CJEU“) has issued a ruling on the interpretation of Directive 2002/46/EC on food supplements, finding that a French law prohibiting the sale of food supplements from other EU Member States containing vitamins and minerals above French national limits is contrary to EU law. The CJEU held that
The new Health Service Medical Supplies (Costs) Act 2017 came into force on 27 April 2017, giving the Department of Health greater powers to control the cost of medicines supplied to the National Health Service (NHS). The cost of branded medicines supplied to the NHS is regulated through two mechanisms – the Pharmaceutical Price Regulation
How do you protect your business from costly Telephone Consumer Protection Act (TCPA) lawsuits and regulatory enforcement actions? In this webinar, we will focus on the key decisions facing company executives as they navigate TCPA risks and assess compliance strategies. Businesses must stay in touch with their customers and their partners in order to succeed. But
When a parliamentary report cites Mary Shelley’s Frankenstein in its recitals and proposes new regulation for robots with artificial intelligence (“AI”), one cannot be sure whether the 19th or the 21st century has inspired the legislator. Last week, the European Parliament took a step to introduce new regulation of robots in Europe. Declaring that the
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications. The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The
The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,
The split of competences between the European Union (“EU”) and its Member States has been a point of friction in the setting out of the future European rules on unmanned aircraft system (“UAS”). In December 2015, the European Commission advocated in its Aviation Strategy for the need for a common regulatory framework across the EU to ensure a single European UAS market. The European Aviation Safety Agency (“EASA”), headquartered in Cologne (Germany), would play a crucial role in defining the common European standards.
On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,
On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.” This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order
As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I. As marijuana remains a Schedule I controlled substance under the federal Controlled Substances Act (CSA), marijuana businesses operating in compliance with state law, and those who contract with such businesses, continue to
FDA announced a final rule today determining that certain common ingredients, most notably triclosan and triclocarban, in over-the-counter consumer antiseptic washes are not generally recognized as safe and effective (GRAS/GRAE), and thus, can no longer be provisionally marketed under the OTC Drug Review. The final rule affects the status of antibacterial soaps, hand washes, and
Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule amending its regulations governing drug establishment registration and listing requirements for U.S. and foreign firms. Also noteworthy is that the final rule expands FDA’s regulations governing National Drug Codes (NDCs). The final rule is available at 81 Fed. Reg. 60170 (Aug. 31, 2016)
Today, FDA published yet another draft guidance targeting drug compounders, entitled Insanitary Conditions at Compounding Facilities (the Draft Guidance). Notably, it makes clear to pharmacy compounders that although they may be exempt from FDA’s current Good Manufacturing Practice (cGMP) requirements, they are not exempt from FDA’s prohibition on insanitary conditions. And FDA, along with state
After the UK Brexit referendum of 23 June the implications on the political, economic and legal relations between the UK and the EU have been discussed from many angles. But what about one of the main pillars for the successful integration of the European Single Market: State aid law? Does the end of EU membership
In a major victory for the Federal Communications Commission’s democratic majority, the U.S. Court of Appeals for the D.C. Circuit upheld the FCC’s 2015 Open Internet Order on June 14, 2016. The 2-1 decision by the D.C. Circuit Court of Appeals likely is not the last word on net neutrality because broadband service providers will
The Federal Communications Commission (“FCC”) is seeking updated information on how the increased adoption of radiofrequency energy-emitting devices is affecting the level of unwanted RF energy emitted from man-made sources (the “spectrum noise floor”). The FCC’s Technological Advisory Council (“TAC”) has launched a technical inquiry to study changes to the spectrum noise floor over the
On 1 June 2016 the European Commission (“EC”) launched four new public consultations relating to clinical trials.
Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model
Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step
On May 17, 2016, a federal judge, citing arbitrary and capricious decisionmaking by FDA and notice-based due process concerns, granted a plaintiff’s emergency motion for a temporary restraining order against FDA, thereby preventing FDA from putting a clinical drug trial on hold with respect to the plaintiff, Eugene “Neil” Fachon. Fachon, a 20-year old student
Standard EN ISO 15223-1:2012 (“The New Standard”) was revised as a part of the new European standard on symbols.
Earlier today, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing a topic affecting the entire pharmaceutical industry—Data Integrity. The guidance, entitled Data Integrity and Compliance with CGMP, Guidance for Industry (Draft Guidance), and styled as a series of questions and answers, is the first guidance document FDA has issued specifically concentrating