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Home » FDA

Articles Tagged with ''FDA''

Regulatory Watch

FDA issues draft chapter for preventive controls guidance

Newest chapter of guidance on hazard analysis released
October 4, 2017

FDA has announced the availability of another draft chapter of “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.”


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FDA logo
Regulatory Watch

FDA amends carcinogenicity testing requirements

Updated regulations eliminate requirement that a sponsor conduct oral, chronic, dose-type studies.
Casey Laughman
Casey Laughman
July 27, 2017
The Food and Drug Administration is amending the regulations governing carcinogenicity testing requirements for food-producing animals.
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Regulatory Watch

FDA allows DUNS number as facility identifier

DUNS number can be used to meet FSVP requirements
June 26, 2017
FDA has formally recognized the Data Universal Number System (DUNS) number as an acceptable unique facility identifier (UFI) for importers under the Foreign Supplier Verification Programs (FSVP) rule.
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FDA inspection
Food Safety

What you need to know before an FDA visit

What your company needs to properly develop, document and implement before an investigation
Richard F. Stier
June 15, 2017
To ensure an FDA inspection is handled properly, it is imperative procedures are in place to do so.
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Regulatory Watch

FDA issues revised guidance for genetically altered animals

The guidance deals with animals whose genomes have been intentionally altered.
April 19, 2017
The guidance applies to both the originally altered animal and its lineage.
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Scott Gottlieb
FDA Commissioner

Gottlieb expected to focus on drug side of FDA

Medical background, experience plays major role in commissioner nomination
Casey Laughman
Casey Laughman
March 28, 2017

Dr. Scott Gottlieb will be taking over as FDA commissioner at an interesting time. 


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FDA
Manufacturing News

GAO evaluates FDA on Produce Safety Rule communications

The rule includes many provisions that have raised many technical and business questions.
January 29, 2017
While the rule establishes enforceable national standards for the on-farm growing, harvesting and holding of domestic and imported produce, it also includes many other provisions that have raised many technical and business questions.
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FDA
Regulatory Watch

FSIS announces companies can use new FDA label format for now

The FSIS will not hold companies in noncompliance if they use the FDA label during the rulemaking period as long as the information is truthful and not misleading.
December 22, 2016
The FSIS will not hold companies in noncompliance if they use the FDA label during the rulemaking period as long as the information is truthful and not misleading.
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black&white FDA logo
Regulatory Watch

FDA releases revised MFRPS standards

FDA issues revised food safety standards for programs overseeing food facitilies
December 16, 2016
Updates include newly defined terms, new section and appendices, updates to current standards.
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FSMA manual
Manufacturing News

FDA: Education is the key to getting on track with FSMA

Companies and FDA inspectors both still learning FSMA
December 13, 2016
Small business and very small business see FSMA compliance dates coming soon.
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