14,474 results found

Last week, FDA announced the release of an enhanced version of a free web-based tool called FDA-iRISK 2.0 that helps users conduct their own quantitative risk assessments in support of food safety.

FDA reopened the comment period for the notice of public hearing, originally published in the February 24, 2014, Federal Register.

In the September 9, 2015, Federal Register, FDA announced it is reopening the comment period on "Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century" to allow interested persons additional time to submit comments.

In the October 14, 2015, Federal Register, FDA announced it is reopening the comment period for the notice of public meeting published on May 13, 2015.

FDA announced it was reopening the comment period for the draft social media guidances.

The initial comment period had just closed on June 9, 2014. Comments are due August 7, 2014.

In the September 24, 2015, Federal Register, FDA announced the opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review...

FDA called for comments on its preliminary list of disease areas for study under FDA's patient-focused drug development initiative under the Prescription Drug User Fee Act.

After reviewing the objections to the final rule, FDA concluded they do not provide a basis for modifying or revoking the regulation.

In the July 7, 2015, Federal Register, FDA announced the revocation of a company's biologics license...

In the July 1, 2014, Federal Register, FDA requested comments on its draft Strategic Priorities Fiscal Year (FY) 2014–2018 document.

FDA announced last week that it will hold a public meeting, titled "FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation,"...

FDA announced a public meeting to discuss two proposed rules aimed at updating nutrition information and serving size requirements on the nutrition facts labels.

In the July 2, 2015, Federal Register, FDA announced its intention to take enforcement action against unapproved and misbranded otic drug products labeled for prescription use.

FDA recently issued a consumer alert advising readers not to be tricked by dietary supplement products that claim to treat concussions and other brain trauma injuries.

FDA announced the withdrawal of three new drug applications and 41 abbreviated new drug applications.

FDA withdrew approval of three abbreviated new drug applications ("ANDAs") for products containing propoxyphene.

In the November 17, 2014, Federal Register, FDA withdrew approval of 14 new drug applications ("NDAs") for the multiple holders' repeated failure to file the required annual reports for the applications.