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FDA Prepping for Push of New Gene and Cell Therapies
FDA Prepping for Push of New Gene and Cell Therapies
In addition to new draft guidance documents on gene therapy-related issues, the U.S. Food and Drug Administration (FDA) will also release guidance on the clinical development of gene and cell therapies, FDA Commissioner Scott Gottlieb said at the Allia...
Texas Joins Multistate Investigation Into Opioid Manufacturers' Role in Nationwide Epidemic
Texas Joins Multistate Investigation Into Opioid Manufacturers' Role in Nationwide Epidemic
Texas Attorney General Ken Paxton last week joined a coalition of state attorneys general who are investigating opioid manufacturers' marketing and sales practices to determine whether the companies have broken any laws, according to The Texas Tribune.
A Hard or Soft Brexit? More Uncertainty for the Life Sciences Industry
A Hard or Soft Brexit? More Uncertainty for the Life Sciences Industry
No-one thought Brexit would be easy and so far, the going has only gotten tougher. UK Prime Minister Theresa May had hoped that by calling an early election that she would have a stronger negotiating position with the European Union (EU). She was wrong.
The Past, Present, and Future of Government Regulation of Off-Label Communications
The Past, Present, and Future of Government Regulation of Off-Label Communications
In 1998, the U.S. District Court for the District of Columbia ruled that FDA’s guidance documents Industry-Supported Scientific and Educational Activities and Advertising and Promotion were unconstitutional because they unduly burdened manufactur...
Martin Shkreli's Trial Shows Just How Angry People Are About Drug Prices
Martin Shkreli's Trial Shows Just How Angry People Are About Drug Prices
Martin Shkreli isn't actually on trial for buying an obscure antiparasitic drug used by AIDS patients and jacking up the price astronomically, but he might as well be.