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If you’d like to be regularly informed of the latest developments at GMP, simply register for our newsletter here.

 
 
PDA Parenterals Conference

From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.

This outstanding event will cover the very important topics:

  • Future of Parenterals
  • Packaging and Impact on Quality
  • Manufacturing Flexibility and Control
  • Innovative Plants
  • Monitoring Technologies
  • Medical and Application Devices
  • Regulatory Trends

Don´t miss this interesting conference in Berlin, Germany.

Brochure of PDA Parenterals Conference 2010, October 26-28

 

News about GMP/cGMP

Draft Guidance Devices (FDA)

By end of April 2010 FDA issued the draft guidance entitled  "FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act" concerning devices.

 

This draft guidance shows how to obtain information on a device and how to submit a request for information.

Outcome:

Interested persons may submit to the Division of Dockets Management written or electronic comments regarding this document.

Written Comments: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Electronic Comments: http://www.regulations.gov.

Link:

FDA/ Draft Guidance

Federal Register/ Draft Guidance

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