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CMC: BIO Comments on FDA Draft Guidance Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products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Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry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CMC: BIO Comments on FDA Draft Guidance CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports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.

Rowan Chapman (Johnson & Johnson) at the 2017 BIO International Convention

Mike Huckman interviews Rowan Chapman (Johnson & Johnson) at the 2017 BIO International Convention Buzz Center.

Daniel Skovronsky (Eli Lilly and Company) at the 2017 BIO International Convention

Mike Huckman interviews Daniel Skovronsky (Eli Lilly and Company) at the 2017 BIO International Convention Buzz Center.

John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals, Inc. at BIO 2017

Mike Huckman interviews John Maraganore, Ph.D., Chief Executive Officer, Alnylam Pharmaceuticals, Inc. at BIO 2017 Buzz Center.

BIO Applauds House Passage of Food and Drug Administration Reauthorization Act (FDARA)

Urges swift Senate vote to ensure continuity of critical FDA functions   Washington, DC (July 12, 2017) – Biotechnology Innovation Organization (BIO) President and CEO James C. Greenwood issued the following statement today regarding passage of the Food and Drug Administration Reauthorization Act (FDARA) by the U.S. House of Representatives: