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November 11, 2019

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When Drug Meets Device

When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility between the components can present a danger to the patient, but how can one demonstrate the fit between a medicinal product and a device? This paper describes the relevant definitions, the existing regulatory framework for combined products (or better the lack thereof), and focuses on stability testing to assess drug or biological-device compatibility.

	Industry News

Aurobindo Recalls 38 Lots of Ranitidine Tablets, Capsules, Syrup
Aurobindo Pharma USA is conducting a voluntary recall of Ranitidine Tablets, Ranitidine Capsules, ... read more »

Purdue, Sackler Family Temporarily Protected from Litigation
Purdue Pharma and the Sackler family will be protected from opioid litigation until April 8, 2020. read more »

Thermo Fisher Scientific, Owlstone Medical Announce Novel Biomarker Collaboration
Thermo Fisher Scientific and Owlstone Medical have entered into a collaborative partnership to ... read more »

SQZ Biotech, AskBio Announce Gene Therapy Research Collaboration
SQZ Biotechnologies and AskBio announced a research collaboration to create TACs containing AAV ... read more »

AbbVie Submits sNDA for IMBRUVICA, Rituximab Combo for Chronic Lymphocytic Leukemia
AbbVie has submitted a sNDA to the FDA for IMBRUVICA with rituximab for the first-line treatment of ... read more »

Bosch Packaging Technology, Parsolex Announce Partnership
Bosch Packaging Technology and Parsolex have entered into a close cooperation on solid dosage ... read more »

	Featured Articles

A Roadmap for Implementing QRM Principles in Drug Substance Manufacturing The ICH Q7 good manufacturing practice (GMP) guidance for active pharmaceutical ingredients (API) ... read more »

It’s Not Easy Being…a Raw Material SMEeeeeee If I wanted to talk to you about raw materials, would your ears perk up? No? You’re not alone. In ... read more »

	Featured Video

Watch Video: Sartorius Stedim Biotech Tour
Sartorius Stedim Biotech Tour read more »

Watch Video: Vi-CELL BLU Viability Analyzer from Beckman Coulter
Watch Video: Vi-CELL BLU Viability Analyzer from Beckman Coulter read more »

	Featured Products

Pegasus GC-HRT High Resolution TOFMS
read more »

HyClone CCM5 Cell Culture Media
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	Featured Whitepaper

Evaluating Integrated Analytics for Single-use Mini Bioreactors
In the past decade, single-use automated micro bioreactors have been widely adopted in biopharma facilities for scaling-down mammalian and microbial cell processes for production of biologics. read more »

Automated Morphological Imaging: Deeper Insight into your Pharmaceutical Formulation or Product
Fully-automated morphological imaging of a pharmaceutical formulation or product can deliver particle size and shape information in a single measurement, and with minimal user intervention. read more »

	Events

CPhI & P-MEC India
Delhi NCR, India – 11/26/2019
As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for ... event details »

Pre-Filled Syringes and Injectable Drug Devices
London, UK – 01/15/2020
Assessing the regulatory environment and future of PFS design and development SMi are pleased to present the 12th Annual Pre-Filled Syringes and ... event details »

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