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10 Mar 2023

GAO to FDA: Do more to encourage drug manufacturing innovation

The Government Accountability Office on Friday released a report calling on the FDA to better encourage the adoption of advanced drug manufacturing practices, particularly as interviews with 15 stakeh
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02 Mar 2023

FDA issues continuous manufacturing advice to build an agile pharma industry

On 1 March, the FDA issued the International Council for Harmonisation (ICH) final guidance on the use of continuous manufacturing in drug production. This publication marks the FDA’s proactive
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21 Feb 2023

Asia-Pacific Roundup: Pakistan finalizes GMP guidelines

The Drug Regulatory Authority of Pakistan (DRAP) has finalized its first set of consolidated guidelines on good manufacturing practices (GMP), overhauling a section on quality control since releasing
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08 Feb 2023

USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a s
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21 Nov 2015

Aseptic Packaging Market Worth $62.46 Billion by 2020

The global aseptic packaging market is projected to be valued at around $62.46 Billion by 2020, growing at a CAGR of 10.66% from 2015. Availability of improved equipment & technologies and emergen
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28 Oct 2015

US FDA issues norms on Allowable Excess Volume & Labeled Vial Fill Size in injectable drugs

US FDA has issued a guidance on Allowable Excess Volume and Labeled Vial Fill Size in injectable drug and biological products. These norms are essentially issued to clarify the Center for Drug Evaluat
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09 Sep 2015

WHO, EU, EMA agreement to improve quality and safety of medicines

With globalized markets and increasing cross-border trade, protecting patients from unsafe, substandard and dangerous medical products requires global action based on information sharing and collabora
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