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DSCSA: BIO files Comments on FDA Draft Guidance Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

November 19, 2018

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Gene Therapy: BIO Comments on Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

November 14, 2018

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BIO Applauds Legislation to Spur Investment in Start-ups

Washington, DC (September 12, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the introduction of the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.

Compounding: BIO comments on FDA Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

May 25, 2018

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CMC: BIO Comments on FDA Draft Guidance Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products

Re: Docket No. FDA-1995-D-0288: Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry

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CMC: BIO Comments on FDA Draft Guidance CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports

 

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DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy

Dear Sir/Madam:

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Nima Farzan (PaxVax) at the 2017 BIO International Convention

Mike Huckman interviews Nima Farzan (PaxVax) at the 2017 BIO International Convention Buzz Center.

Khyati Roberts (Abbvie) at the 2017 BIO International Convention

Mike Huckman interviews Khyati Roberts (Abbvie) at the 2017 BIO International Convention Buzz Center.

Jay P. Siegel, MD (Johnson & Johnson) at the 2017 BIO International Convention

Mike Huckman interviews Jay P. Siegel, MD (Johnson & Johnson) at the 2017 BIO International Convention Buzz Center.