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Keller and Heckman LLP | USA | 17 May 2022

FDA Releases Guidance on Infant Formula Enforcement Discretion Policy

Yesterday FDA released a guidance document which lays out the Agency’s plan to help increase the supply of infant Formula in the U.S through the…
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DLA Piper | Chile | 17 May 2022

Chile • Ley REP: Catálogo de productos que se consideran “Envases”

La Ley N° 20.920 del año 2016, conocida como “Ley REP”, con el fin de otorgar un nuevo marco legal en materia de residuos y Fomento al reciclaje…
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DLA Piper | USA | 17 May 2022

FDA premarket approval and the use of “FDA Approved” claims

“FDA Approved” claims are often used, and misused, in the advertising and marketing of a number of FDA-regulated products. In recognition of this…
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Reed Smith LLP | USA | 16 May 2022

Ninth Circuit - First Amendment Prevails Over Prop 65

California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer”…
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Keller and Heckman LLP | USA | 16 May 2022

FDA Finalizes Guidance on Reducing Microbial Hazards in Seed for Sprouting

As covered on this blog, FDA announced a draft guidance on June 25, 2019 for the seed sprouting industry that provides recommended steps to prevent…
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Baker McKenzie | Italy | 16 May 2022

Italy: Liability of the manufacturer for damages caused by the break of medical devices

With judgment No. 2149 dated 19 January 2022, the Court of Cassation acknowledged the liability of a manufacturer of medical devices for…
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Harris Bricken | USA | 16 May 2022

Why the DEA Hemp Rule Challenge Really Matters

The Drug Enforcement Administration (DEA) issued an interim final rule on hemp (“DEA hemp rule” or “rule”) on August 20, 2020. As per its executive…
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Duane Morris LLP | USA | 16 May 2022

Cannabis: NJ Assembly Passes Decriminalization Bills for Possession of Certain Amounts of Cannabis

The NJ Assembly passed two bills, 1897 and 4269 that would decriminalize possession of certain amounts of cannabis, while reducing penalties for what…
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Hogan Lovells | Brazil | 16 May 2022

Brazil requires drug makers to add QR codes in package inserts and implement traceability systems

A new law was enacted in Brazil on May 12, 2022 (Law No. 14,338/2022) requiring that medicine package inserts will have to be provided in digital…
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Duane Morris LLP | USA | 16 May 2022

California Governor Proposes a Cannabis Tax Reduction in an Effort to Shore Up the Legal Market

On Friday, May 13, California Gov. Gavin Newsom introduced proposed revisions to his 2022-2023 budget proposal, which would eliminate the cannabis…
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