Pharmaceutical Technology-11-02-2018

Pharmaceutical Technology

Guidelines on Integral Drug-Device Combinations

November 12, 2018

Regulatory Watch

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Pharma companies are concerned they may have to postpone plans for the commercialization of new combination products because of delays in obtaining marketing authorizations because of a lack of clarity about approval rules.

User Requirements Specifications–How Difficult Can It Be?

November 02, 2018

Ask the Expert

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Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.

Innovation and Industry Strength Recognized at CPhI

November 02, 2018

From The Editor

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Survey results and record attendance show positive signs for various bio/pharma regions.

Pharmaceutical Technology North America, November 2018 (PDF)

November 02, 2018

Issue PDF

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Click the title above to open the Pharmaceutical Technology November 2018 issue in an interactive PDF format.

Fasten Your Seatbelts …

November 01, 2018

From The Editor

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… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.

FDA Promotes Complex Generics and Combination Products

October 19, 2018

Regulatory Watch

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To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.