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FDA Releases Guidance On CMC Changes To An Approved Application Certain Biological Products

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 to an approved application. This guidance finalizes the draft guidance, Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products, dated December 2017, and supersedes the guidance titled Guidance for Industry: Changes to an Approved Application: Biological Products, dated July 1997. The guidance describes general and administrative informat ....

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FDA Releases Guidance On CMC Changes To An Approved Application Certain Biological Products

FDA Releases Guidance On CMC Changes To An Approved Application Certain Biological Products
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.

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Ohio legislature passes solar and wind project siting and approval bill

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 signs the bill, it would become effective in 90 days. ....

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Aprovado Requerimento de Urgência para votação do projeto de Refinanciamento dos Tributos Federais

Aprovado Requerimento de Urgência para votação do projeto de Refinanciamento dos Tributos Federais
engeplus.com.br - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from engeplus.com.br Daily Mail and Mail on Sunday newspapers.

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