Gene therapy investigations proliferate

Article Abstract:

Jesse Gelsinger is the first person to have died from gene therapy, and controversy surrounds the issues of informed consent and documentation and reporting violations in this case. All 7 gene therapy trials initially authorized by the Food and Drug Administration have been suspended until the investigation is complete.

Cases, Laws, regulations and rules, Informed consent (Medical law), Informed consent, United States. Food and Drug Administration

---

New measures introduced to monitor gene therapy trials

Article Abstract:

The US FDA will closely examine all clinical trial monitoring plans submitted by gene therapy researchers following the death of a patient who received gene therapy. The National Institutes of Health will even visit trial sites to make sure researchers understand the requirements for reporting adverse reactions.

United States, Investigations, Medical research

---

Gene patent revisions to remove some controversies

Article Abstract:

The US Patent and Trademark Office will no longer award patents based on expressed-sequence tags (ESTs). ESTs are cDNA fragments between 200 and 400 bases long and the USPTO claims these fragments are not sufficient to describe the genes they are associated with.

Science and technology policy, Intellectual property, Human genetics, United States. Patent and Trademark Office

Similar abstracts:

• Abstracts: In the wake of insurance reform: states revamp laws to meet new federal rules. Dueling proposals for kids' health insurance; lawmakers seeking plan everyone can live with
• Abstracts: Methylnaltrexone for Reversal of Constipation Due to Chronic Methadone Use: A Randomized Controlled Trial. Herbal Medicines and Perioperative Care
• Abstracts: The Rapid Test Paradox: When Fewer Cases Detected Lead to More Cases Treated. Medical Care Expenditures for Genital Herpes in the United States
• Abstracts: Managing the confused patient. Mirror, mirror on the wall. How come we're losing if we scored the equaliser?
• Abstracts: Reduction of postoperative pain: a double-blind, randomized clinical trial. The performance of bonded vs. pin-retained complex amalgam restorations: a five-year clinical evaluation

This website is not affiliated with document authors or copyright owners. This page is provided for informational purposes only. Unintentional errors are possible.