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New UK Brexit Health Alliance Formed

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,

Extension to the EMA’s Multinational Assessment Team Initiative as of April 2017

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

EMA on CVMP strategy on antimicrobials 2016-2020

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

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,

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

India’s New BIT and Arbitration Law Send Mixed Signals to Foreign Investors

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.

FDA Settles Pacira’s First Amendment Lawsuit

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

Industry – HCP Relations Soon Subject to Tougher Regulations in France?

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

KNOWLEDGE ALONE ≠ INTENT: FDA Proposes To Trim One Basis for Determining “Intended Use” of Drugs and Devices

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 Fifth Circuit’s Migratory Bird Treaty Act decision in Citgo has broad implications for the U.S. Fish & Wildlife Service’s enforcement and permitting programs

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

U.S. FOREST SERVICE WITHDRAWS PROPOSED GROUNDWATER GUIDANCE: Sometimes the Government Listens

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

FCC Clarifies TCPA Requirements, Creating New Burdens on Callers

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

Department of Energy issues Final Rule amending its nuclear export control regulations

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

Congress Agrees on Six-Year Reauthorization of Terrorism Risk Insurance Act (TRIA)

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.

FCC Issues Notice of Violation to Nike for Corporate Wireless System

In the latest example of increased FCC enforcement activity, the agency’s Enforcement Bureau has issued a Notice of Violation to Nike Inc., for interference caused by a defective UHF amplifier card in Nike’s corporate Distributed Antenna System (“DAS”) network.  The Notice is an important reminder for all companies that operate wireless equipment to keep a

AWS-3 Auction Revenue Surpasses $16 Billion

After four days and fifteen rounds of bidding, bidding for paired spectrum in the AWS-3 spectrum auction (Auction 97) remained very strong today.  Total revenue accelerated past its $10+ billion reserve price this morning and closed the day in excess of $16 billion.  The current revenue level ensures that Auction 97 will fully cover the