How to Respond When OSHA Knocks
Seyfarth Synopsis: Seyfarth Shaw’s OSHA/MSHA group is at the ABA’s Occupational Safety and Health Law Committee Midwinter Meeting this week. ...more
On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more
The Basic Conditions of Employment Act (BCEA) was amended to cater for: The amendments also provide for claims for underpayment of the minimum wage. The definition of "basic conditions of employment" has been amended to...more
Earlier yesterday, FDA published the final guidance “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” which updates April 2016 draft guidance that covers the design, operation, and monitoring of systems...more
Earlier yesterday, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance...more
In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon implementation, this regulation replaced...more
In Regulatory Notice 17-38 (Regulatory Notice), the Financial Industry Regulatory Authority (FINRA) requests comments on a proposal (Proposal) to amend FINRA’s Conduct Rule 3110 (Supervision). ...more