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最新的帖子

五月 02, 2019

FDA Guidance Affecting cGMP Compounding Pharmacies (503Bs)

Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),<sup>1</sup> compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.<sup>2</sup>
Amy Kim

Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

以前的博客
SmartDose Platform

四月 26, 2019

Overcoming Challenges Associated with Biologic Drug Formulation and Development

Victoria Morgan

Victoria Morgan

Director, Segment Marketing, Global Biologics

Leo Posner of Johnson & Johnson presenting at the PDA Combo Workshop

四月 03, 2019

The Challenges of Combination Products

Fran DeGrazio

Fran DeGrazio

VP, Technical Services and Scientific Affairs

Introducing Integrated Solutions

十月 08, 2018

Introducing Integrated Solutions

Deirdre Swinden

Deirdre Swinden

Director, Marketing Communications

The SmartDose Platform in use

八月 10, 2018

Combination Products - Why Design Verification Studies Are Needed

Daniel Bantz

Daniel Bantz

Technical Manager, Packaging & Performance, Lab

SmartDose Platform

八月 08, 2018

Performance Testing: Strategies to Qualify Combination Products

Page McAndrew

T. Page McAndrew, Ph.D.

Director, Scientific Communications, SA & TS

Mixject Admixture System

一月 30, 2018

Co-Packaged Combination Products – System vs Component

Doug Hostetler

Doug Hostetler

Principle SME, Admin. Systems, TCS

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