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Drug & Device News
To Address Shortages, FDA Allows Import of Unapproved Cancer Drugs
Responding to concerns that supplies of certain cancer treatment drugs had become dangerously short, the U.S. Food and Drug Administration (FDA) took steps in February to address the crisis; the agency temporarily authorized the import of two unapproved medications. The FDA announced it would allow the importation of the drug Lipodox (doxorubicin hydrochloride liposome injection), manufactured by India's Sun Pharma Global, to replace Doxil (doxorubicin hydrochloride liposome injection). Doxil, which is commonly used to treat certain ovarian cancer patients and patients with AIDS-related Kaposi's sarcoma or multiple myeloma, became scarce after the drug's manufacturer shut down production at its Ohio facility late last year. The FDA, which in rare emergency circumstances allows the importation of unapproved drugs that are critical to patients, expects the Lipodox imports to meet all U.S. patient needs.
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New York's Latest Cybersecurity Commitment
On Aug. 9, 2023, Gov. Kathy Hochul introduced New York's inaugural comprehensive cybersecurity strategy. In sum, the plan aims to update government networks, bolster county-level digital defenses, and regulate critical infrastructure.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.