by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News
FDA issues guidance and recommendations for New Drug Applications (NDA) and Biologic Laboratory Applications (BLA) which implicate oncology therapies and warrant Real time Oncology Review (RTOR). On July 25, 2022, the FDA, by and through the Oncology Center for...
by Ismail Amin | Jul 25, 2022 | Biotech Bulletin, News
FDA guidance regarding consumer health products and the enforcement of Global Unique Device Identification Database submission requirements. In its July 25, 2022, guidance document – The FDA (by and through the Center for Biologics Evaluation and Research and...
by Ismail Amin | Jul 11, 2022 | Business Law, News
When does “Puffery” constitute Investor-Fraud?For many companies seeking to raise capital, an important 9th circuit case is illustrative of what exactly constitutes actionable puffery, which would generally constitute a false and misleading material statement to...
by Dima Hanna | Jul 5, 2022 | Business Law, News
It is a common presumption that when a business owner incorporates their company or registers it as an LLC, they become protected from being held personally liable for any debts incurred by the business. Although this may be true to a certain extent, it does not...
by Scott Halberstadt | Apr 27, 2022 | COVID-19 Updates, News
While employers generally understand that they owe a duty to maintain the safety of their employees while those employees are in the scope of their employment, can an employer be responsible for the health, welfare and safety of an employee’s family? As a result of...
by Dima Hanna | Apr 13, 2022 | Intellectual Property, News
The right to copyright protection is outlined in the U.S. Constitution to protect the rights of those who produce content; however also embedded in the Constitution is the idea that the “progress of science and useful arts” must be promoted. U.S. Const. Art. I, § 8,...
