Top Stories
Robert Califf has been confirmed by the US Senate as FDA commissioner.
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The company filed a writ of certiorari for the court to review a July 2015 decision by a Federal Circuit court that determined the patent dance in the BPCIA are not mandatory.
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The  2016 PDA Annual Meeting provides the latest and most comprehensive information about innovative biopharmaceutical approaches, bioprocessing technologies and manufacturing sciences for development and commercialization. Learn how accelerated product development, expanding access to medicines and personalized treatments will impact the future of manufacturing. Opportunities abound to network with industry and regulatory experts and colleagues from around the world.
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Industry News
Recipharm plans to invest €40 million in the project as a result of an EMA decision to make serialization of licensed drug products a legal requirement by 2019.
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The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.
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Supplier News
Unchained Labs acquires Freeslate, marking the company's fourth acquisition in the past 12 months.
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The collaboration will allow the companies to develop and manufacture novel inhaled therapeutics.
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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
LIVE WEBCAST: Wednesday, March 23, 2016 at 8 am PDT / 10 am CDT / 11 am EDT
Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
 Register now |
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Bio/Pharma News
FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.
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Researchers discovered more than 300 antibodies that reacted with the Ebola virus's surface glycoprotein and could be used to neutralize many strains of the virus.
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Regulatory News
The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.
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The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.
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Engineering the Mechanical properties of Amorphous Spray-Dried dispersions
On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.
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FEATURED TOPICS |
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MANUFACTURING
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
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PEER-REVIEWED RESEARCH
A novel method, based on differential calculus, was used to calculate the maximum potential error associated with the drug concentration in pharmaceutical mixtures composed of an infinite number of ingredients measured on an infinite number of balances with different sensitivities.
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TROUBLESHOOTING
Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.
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EU REGULATORY WATCH
The EU's key objectives include improving medicines access, tackling drug shortages, and increasing administrative efficiency in its regulatory framework.
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Best Practices for Effective Product Transfer
On Demand
Understanding all aspects of the product transfer process is critical to a successful transfer and delivery of a quality product. During this one-hour webinar, regulatory and pharma experts will discuss the critical elements and processes needed for an effective, compliant product transfer process and successful end results.
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Webcasts
On Demand
Learn about adaptive clinical trials, patient recruitment strategies, and advanced biomarker analysis tools designed that can accelerate drug development and clinical testing processes.
Sponsored by SGS
On Demand
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Sponsored by Baxter
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on pharmtech tv
Continuous Manufacturing in Solid-Dosage Drug Production
Pain in the (Supply) Chain Survey
Compliance and Technology for Track and Trace
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Events
March 14-16, 2016
April 26-28, 2016
June 6-8, 2016
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REFERENCE BOOKS |
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A compilation of informative, useful articles designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
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eBOOKS
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This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.
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