Tag Archives: OMB

EEO-1 “Part 2” Pay Data Report Roars Back to Life

In a stinging rebuke of the Trump Administration’s attempt to remove burdensome regulations on employers, Judge Tanya Chutkan, a District Court judge in the District of Columbia this week reinstated the EEO-1 “Part 2” wage data/hours worked reporting form for all employers who file annual EEO-1 demographic reports with the Equal Employment Opportunity Commission (“EEOC”) and the U.S. Department of Labor. (This includes all companies employing more than 100 people, or 50 people if they are a US federal contractor.)

Read more

Read full article
ILN Today Post

FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

Read more

Read full article

FDA Reexamining Communication Practices with Investigational New Drug Sponsors

On November 19, 2018, the FDA submitted a proposal to the White House Office of Management and Budget (OMB) to approve a review that will assess current communication practices between FDA review staff and Investigational New Drug (IND) sponsors.  The FDA has contracted with Eastern Research Group (ERG) to determine whether the current mode of communication between these parties needs to be adapted moving forward.  Depending on the results of this review, communication practices and requirements could be altered, which might have an effect on the IND application process. Possible modifications might occur that could assist in removing communication bottlenecks hindering approval timelines.

Read more

Read full article