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Bradley Arant Boult Cummings LLP

Solar Industry Group Releases New Standard for Solar Supply Chain Transparency

The Solar Energy Industries Association (SEIA), a leading solar industry group, recently published a new supply chain traceability standard, Standard 101, for public comment. The standard is intended to provide “a rubric that...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Hogan Lovells

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open!

Hogan Lovells on

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices....more

Hogan Lovells

UK MHRA to develop quality standards for biological medicines

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines....more

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