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What’s Up With Water – June 21, 2021

Circle of Blue

Drought Monitor categories. Wells are regulated at the county level, not the state. That’s according to Sarge Green, a consultant to the Partnership for the San Joaquin Valley, a forum for regional collaboration. The post What’s Up With Water – June 21, 2021 appeared first on Circle of Blue.

2021 246
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New Developments in China’s Drug Change Management Regulations

Arnold Porter

It is the latest development in China’s regulations of drug change management since the promulgation of the newly amended Drug Administration Law in 2019 and more than 20 regulations and technical guidelines. Latest Developments in China’s Drug Change Management Regulations. ???????????????.

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As a Hot, Dry Summer Begins in California, More Water Wells Are Failing

Circle of Blue

By Brett Walton, Circle of Blue – June 17, 2021. A rough estimate from the Public Policy Institute of California found that if groundwater levels decline at the same rate as in the last drought, about 2,700 wells could go dry in 2021. Drought Monitor categories. Counties, not the state, regulate new wells.

2012 363
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Proposed Amendments to AICIS General Rules Include Clarifying Criteria for Industrial Chemicals Introduced at the Nanoscale

Nanotech

According to Australia, after the first year of operation of the Australian Industrial Chemicals Introduction Scheme (AICIS), the regulated industry and staff within the Office of Chemical Safety have identified “minor operational issues” that require amendments to the details set out in the Ministerial Rules. Transitional provisions.

2019 52
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Research Roundup: FDA Uses Fall and Winter 2021 to Release Significant New Guidance Governing Hot-Button Life Sciences Research Topics

Arnold Porter

FDA’s decision to issue this investigator-specific guidance follows publication of a draft sponsor-specific safety reporting guidance in June 2021, and is part of an effort to ultimately replace the older guidance documents with role-specific guidance. 2021) (RWE Draft Guidance). A summary of these documents follows below.

2021 52
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FDA Seeks Comments on Transition of Certain Drugs to Device Status Following Genus DC Circuit Decision

Arnold Porter

This question, and FDA’s discretion to determine a product’s regulatory classification, was at the heart of the DC Circuit’s April 2021 decision in Genus Med. Under the FDCA, whether a product is regulated as a drug or device turns on the intended use of the product. N: Genus Med. Food and Drug Administration, 994 F.3d

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Department of Commerce Eliminates Most Mass Market Encryption Reporting Obligations

Arnold Porter

However, Commerce notes that most cryptographic libraries and modules themselves will likely not be impacted by this change because the mass market note (Note 3 to Category 5, Part 2 or the "Cryptography Note") specifically excludes items whose primary function is "information security.". c or 5D992.c Conclusion.