The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
8/10/2021
/ Final Rules ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Regulatory Oversight ,
Regulatory Reform
Over the last four months, we have tracked the District of New Jersey’s proposal and adoption of a new Local Civil Rule – L. Civ. R. 7.1.1 – requiring lawyers to disclose details about third-party litigation funding. The...more
The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding. On June 21, 2021, Chief Judge Freda L. Wolfson signed...more
The United States District Court for the District of New Jersey has announced proposed amendments to its Local Civil Rules, including a new rule – Civ. Rule 7.1.1 – regarding “Disclosure of Third-Party Litigation Funding.” ...more