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Category Archives: Regulatory

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UK ‘Sugar Tax’ – Draft Regulations Published

The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018. The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5

UK Food Standards Agency reviewing Feed Law Code and Guidance

The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

Majority in favour of improving fairness in EU food supply chain

Initial responses to the European Commission’s public consultation on how to make the EU food supply chain fairer suggest that, bar retailers, the majority of significant stakeholders (including Member States, farmer groups, agricultural organisations and NGOs) are in favour of action at EU level to increase fairness and balance in the food supply chain. The

Gender stereotyping in UK advertising – staying on the right side of the line

Unlike some other European countries, the UK does not currently have specific rules prohibiting or restricting gender stereotyping in advertising. To date, complaints about ads featuring stereotypical gender roles or characteristics have been brought based on the requirement in the UK non-broadcast and broadcast advertising codes (the CAP Code and BCAP Code) that advertising must

#Ad and the challenges of native advertising and social influencers

Westminster Media Forum recently hosted a seminar to discuss native advertising and social influencer marketing and their measurement, regulation and impact on brands. Industry insiders, advertising agencies, content producers, publishers, influencers and regulators joined forces to discuss the challenges faced by these new models of advertising. Central to these latest trends is the shift in

FDA Launches New Tool For Accessing Drug Adverse Event Information

FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products.  FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and

UK Publishes Draft Legislation Prohibiting the Manufacture and Supply of Cosmetic Products Containing Microbeads

On 11 September 2017, the UK Department for Environment, Food and Rural Affairs (DEFRA) published draft regulations prohibiting the manufacture and supply of rinse-off personal care products containing microbeads. The draft Regulations (available here) are to be laid before the UK Parliament for approval. Under the draft legislation: companies will be prohibited from manufacturing such

ECJ sides with farmers on genetically modified crops

The European Court of Justice has held that Member States may not adopt emergency measures prohibiting genetically modified food and feed (GMOs) unless there is clear evidence that a particular GMO presents a serious risk to health or the environment in accordance with Article 34 of the GMO Regulation (EC) No 1829/2003. Ruling in favour

To certify or not to certify? FDA has answered the question

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.  

CJEU upholds principle of free movement of goods for food supplements

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

UK Government Given Additional Powers to Control NHS Medicine Prices

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

TCPA for the Boardroom – An Executive Focus

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

Regulate Frankenstein: the European Parliament calls for new rules for robots

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

UK MHRA publishes “top tips” for manufacturing authorisation applicants

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

Scottish government to reform approval process for new end-of-life and orphan medicines

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 European Parliament pushes for an EU-wide regulation for UAS

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.

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

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,

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

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

Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness

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

Certain Antiseptic Ingredients No Longer GRAS/GRAE, Says FDA

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

FDA Revises Its Drug Establishment Registration, Drug Listing, and National Drug Code (NDC) Regulations

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)

New Guidance Makes Clear that FDA Is Focused on Insanitary Conditions at Pharmacy Compounders

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