Drug Master Files Guidance for Industry
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Drug Master Files Guidance for Industry

This guidance provides FDA’s current thinking on drug master files (DMFs), which are 17 submissions to FDA that may be used to provide confidential, detailed information about 18 facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of 19 human drug products.

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Good practice guidance for communication to the public on medicines’ availability issues
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Good practice guidance for communication to the public on medicines’ availability issues

Medicine shortages or problems relating to the availability of medicines are a multifactorial problem
involving a wide range of stakeholders, from patients and animal owners to the pharmaceutical
industry. In addition to measures to improve reporting and management of availability problems,
measures aimed at improving communication of such issues to the public play an important role in
minimising their potential impact.

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Safety Features for Medicinal Products for Human Use
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Safety Features for Medicinal Products for Human Use

This documents sets out frequently-asked ‘questions and answers’ regarding the implementation of the rules on the safety features for medicinal products for human use.
These rules are enshrined in Articles 47a, 54(o) and 54a of Directive 2001/83/EC, and in Commission Delegated Regulation (EU) 2016/1612.

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Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
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Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container

Guidance is provided on the selection of appropriate methods of sterilisation for sterile products.
Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. Eur.)
is the method of choice whenever possible, this guideline provides information on when other terminal
sterilisation processes, sterilising filtration or aseptic processing, (either alone or when combined with
an additional post-aseptic processing terminal heat treatment), could be accepted as an alternative.

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