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On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
In a precedential opinion issued on April 11, 2024 in Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals Inc., Nos. 22-2153, 23-1952, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for...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- On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more
The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...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
The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to...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
On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more
On February 3, 2015, FDA published a notice in the Federal Register requesting comments on information collection in an application for a proposed biosimilar and a supplement for a proposed interchangeable product....more
Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more