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For nearly two decades, U.S. Citizenship and Immigration Services (USCIS) has signaled its intention to modernize with the creation of an electronic filing system officially known as the Electronic Immigration System or ELIS
This new FDA/CDER guidance represents the FDA's thinking regarding the types of changes to an approved biologics license application (BLA) that...
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products By Mark Durivage, Quality Systems Compliance LLC On June 21, 2021, the FDA released a new guidance, Chemistry, Manufacturing, and Controls Changes (CMCs) to an Approved Application: Certain Biological Products, to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA) as specified in 21 CFR 601.12 Changes...
It’s been a long and winding road to the Governor’s desk for Senate Bill 52, the controversial bill on siting and approval of large-scale wind and solar facilities in Ohio. The bill generated opposition and concern from the outset, requiring a major overhaul early on. A substitute bill passed the Senate on June 2 after six hearings and hundreds of witnesses testifying for and against the bill. It took the House five hearings to pass a further revised version of the bill, and the Senate agreed to those revisions the same day. Now the bill awaits Governor DeWine’s action. If the Governor ...