Law School Toolbox Podcast Episode 399: Bringing Your A-Game to OCI (w/Sadie Jones)
PODCAST: Williams Mullen GovCon Perspectives - Recent Updates to the SWaM Certification Process in Virginia
Mind the Gap: Establishing Need/Gap in Coverage
IP|Trend: Inter Partes Review: What to Consider When Filing Your Petition
Law School Applications Crater
LXBN This Week Ep. 2: EEOC on Criminal Records & Transgender Discrimination, BP Oil Spill Arrest, AZ Immigration Law at SCOTUS
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
The Ohio Department of Health (ODH) has prepared draft amendments to Ohio’s Certificate of Need (CON) rules. A number of these draft rule amendments address changes to the CON laws that were made in Ohio’s general operating...more
On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more
In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more