The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to centrally authorised medicinal products. Market Authorisation Holders (MAHs) may need to fulfil post-authorisation measures by providing additional data on safety, efficacy and quality
EPA and NHTSA are currently conducting a Mid-term Evaluation as part of the 2012 GHG emission standards established for MY 2017-2025 passenger cars and trucks. Pursuant to the 2012 rulemaking, EPA committed to conduct a Mid-term Evaluation of the GHG standards for MY 2022-2025 light-duty vehicles. As part of the Mid-term Evaluation, EPA issued for
A “Brexit Health Alliance” (BHA) has been formed to bring together a diverse range of UK stakeholders in the healthcare industry and provide a single voice for the sector on Brexit-related issues. Members of the BHA include NHS organisations, industry associations, universities, research organisations and charities, the Royal Colleges, such as NHS Confederation, NHS Providers,
Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for
On 7 October 2016, the European Medicines Agency (“EMA”) issued a press release to announce the adoption by the Committee for Medicinal Products for Veterinary Use (“CVMP”) of the revised CVMP strategy on antimicrobials for the period 2016-2020. Background The present revision of the CVMP strategy on antimicrobials seeks to take into account the scientific
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,
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
In October 2015, the UK Prime Minister published an updated version of the Ministerial Code, his guidance to government ministers on how they should conduct themselves in public office. Prior to the revision, paragraph 1.2 read: The Ministerial Code should be read alongside the Coalition agreement and the background of the overarching duty on Ministers
The tax and spending bill signed into law by President Obama last week included a two year suspension of the medical device excise tax. After years of effort by industry to abolish the tax, proponents of the suspension speculate that it may represent a window to full repeal. Read More: Congress Suspends Medical Device Tax for Two
On December 28, 2015, the Government of India released the text for its revised model Bilateral Investment Treaty (BIT). In this release, the Government of India also announced that the Department of Economic Affairs will be leading all negotiations on BITs and investment chapters of trade agreements to ensure continuity between trade and investment issues.
Pacira has announced that it settled its lawsuit against FDA over the labeling and promotion of its postsurgical analgesic drug, EXPAREL®. FDA approved EXPAREL (bupivacaine liposome injectable suspension), in October 2011 for “administration into the surgical site to produce postsurgical analgesia” based on two clinical trials involving pain after bunionectomies and hemorrhoidectomies. Although the drug’s
In France, anti-benefits regulations prohibit the health industry from offering direct and indirect benefits of any kind to HCPs, except in very limited circumstances. These regulations also establish a consultative process requiring the prior opinion of professional bodies, in particular on the fair market value of payments made to HCPs. These regulations apply to companies
Last week, the U.S. Food and Drug Administration (FDA) published a proposed rule, 80 Fed. Reg. 57756 (Sept. 25, 2015), that at first blush is devoted to clarifying when a tobacco product may be subject to FDA’s regulation as a drug, device, or combination product vs. a tobacco product. Slipped within this proposed rule, however,
The Court of Appeals for the Fifth Circuit reversed Citgo Petroleum Corporation’s criminal conviction in the Southern District of Texas and held that the Migratory Bird Treaty Act’s (MBTA) ban on bird “takings” only prohibits intentional acts that directly kill migratory birds. In addition to the operation of oil and gas facilities, the Fifth Circuit
A concise Friday announcement in the Federal Register, 80 Fed. Reg. 35,299 (June 19,2015), brings notice that the U.S. Forest Service has abandoned plans for major revisions of its groundwater management policy, Forest Service Manual 2560, at least for the time being. Although the Forest Service attributed its reversal to a determination that the “proposal does
Today, the Federal Communications Commission (FCC) adopted a Declaratory Ruling and Order clarifying a number of unsettled issues under the Telephone Consumer Protection Act (TCPA). The decision, which has not yet been released, is in response to more than twenty petitions seeking clarification. The vote was 3-2 along party lines and is expected to have
FDA announced last week that it was withdrawing numerous draft guidance documents including its 2004 draft guidance on disease awareness activities
On 8 March 2015, President Obama signed Executive Order 13692 (the Order) imposing targeted sanctions against persons in Venezuela.
On 23 February 2015 the Department of Energy (DOE) published a Final Rule in the Federal Register (80 Fed. Reg. 9359) (Final Rule) to amend the Part 810 Regulations (10 C.F.R. Part 810), which govern the export and re-export of unclassified nuclear technology and assistance. This Final Rule is the first comprehensive updating of the
An ongoing debate about the authority of the U.S. Federal Communications Commission (FCC) and the Federal Trade Commission (FTC) to regulate broadband may soon come to a head. AT&T recently asked a U.S. district court to dismiss a complaint filed against it by the FTC. The motion to dismiss challenges the FTC’s authority to regulate
After failing to pass a TRIA reauthorization during the lame duck session last Congress, on January 7, 2015, the House passed H.R. 26, the Terrorism Risk Insurance Program Reauthorization Act of 2015, by a vote of 416-5. Shortly after on January 8, 2015, the Senate passed H.R. 26 by a 93-4 vote. Upon the President’s signature, TRIA will be reauthorized until December 31, 2020.