by Ismail Amin | Aug 15, 2022 | Biotech Bulletin, News
In the selection of a Clinical Research Organization (CRO), the Sponsor must ensure that the CRO has careful policies and procedures in place to safeguard protected patient information. Also, Sponsors should evaluate their own privacy protection policies and SOPs in...
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 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 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 Ismail Amin | Mar 28, 2022 | Business Law, News
1. SEC’s Proposed Rule Regarding Cybersecurity Breach Notifications On March 9, 2022, the United States Securities and Exchange Commission (“SEC”) has proposed a rule requiring publicly traded company to disclose “material” cybersecurity breaches within 4 days of the...
