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Sanofis Admelog OKd as Humalog Follow-on Product

[ Price : $8.95]

FDA approves Sanofi-Aventis Admelog (insulin lispro injection), a Humalog follow-on and short-acting insulin indicated to improve ...

CDER Outlines Internal Research on 3D-printed Drug Products

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CDERs Office of Testing and Research outlines research it is conducting to better understand 3D or additive manufacturings use in ...

FDA Approves Intersect PMA for Sinuva

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FDA approves an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent...

Workshop on Software Precertification Program

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Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled Fostering Digital Health Innovation: Developing the...

Comments Sought on Oncology Center of Excellence Functions

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Federal Register notice: FDA announces a 3/15/2018 public meeting entitled Oncology Center of Excellence: Listening Session.

Mylan Petitions FDA for Strict Bioequivalence on Advair Generics

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Mylan petitions FDA to require strict bioequivalence study designs for ANDA applicants seeking to market generic versions of Glaxo...

Sen. Warren Seeks $5B Funding/Research Boost for FDA and NIH

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Senator Elizabeth Warren (D-MA) introduces the National Biomedical Research Act that would increase funding for targeted biomedica...

Comments Sought on User Fee Performance Assessment

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Federal Register notice: FDA seeks comments on a statement of work to assess current practices when communicating during IND devel...

FDA Posts Annual Report on Postmarketing Study Requirements

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Federal Register notice: FDA posts its annual report on the status of drug/biologic postmarketing requirements and postmarketing c...

FDA Clears Genea Biomedx Benchtop Incubator

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FDA clears a Genea Biomedx 510(k) for its benchtop incubator Geri.