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Posted 15 June 2012 | By Alexander Gaffney, RAC
Regulatory Focus is proud to bring you another edition of Week in Review-a recap of the global regulatory news space for the preceding week. We cover news and regulatory intelligence from around the globe and bring it to you in one organized location. If you read just one thing this week, make it Regulatory Focus' Week in Review.
Previous Week in Reviews: [4-8 June][21-25 May] [14-18 May] [7-11 May] [1-4 May] [23-27 April]
DHHS Looks to Reduce Dependence on Animals in Preclinical Testing
The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies.
New Patent Rules Could Make China Compulsory Licenser to the World
Following closely in the footsteps of India, China has announced the release of a new patent system in which it can grant compulsory licenses to generic pharmaceutical manufacturers to allow them to make copies of on-patent branded medicines.
FDA Announces Planned Update to Electronic Common Technical Document
The US Food and Drug Administration (FDA) announced its intent to hold a meeting to update stakeholders on the changes it plans to make to Module 1 of the Electronic Common Technical Document (eCTD), which is used to describe administrative and prescribing information for medicines.
Panel Starts Investigation of India's Drug Regulatory Authority
India's regulatory authority, the Central Drugs Standard Control Organization, has not had a particularly good start to 2012. Accounts of corruption and incompetence have been echoed in numerous reports, and now a panel of experts is set to dig further into the agency in the hopes of recommending needed reforms.
Pharmaceutical and Biologics
Other US News
Compliance and Safety Issues
Deals and Acquisitions
Regulation and Guidance
Other EU News
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...