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
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- On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more
With much of the cannabis oriented media focusing on the flurry of adult use bills and opportunities, it is easy to overlook that many states are doubling down on their medical marijuana infrastructure. For instance, over...more
According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 billion. The CAM industry, which...more
On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications....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for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more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The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.”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
On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more
On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance...more
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more
Marylanders can shop for coverage through the Marketplace’s new mobile app; Michigan expansion enrollees report increased access to care and improved health; and survey finds states’ eligibility and enrollment systems...more
In Ferring B.V. v. Fera Pharmaceuticals, LLC, the Eastern District of New York was called upon to determine the importance of the United States Patent and Trademark Office’s Trademark Manual of Examining Procedure (“TMEP”)...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