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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to continue its oversight activities.
FDA recently issued its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health (NIH) databank. Despite having authority to issues such notices since the 2007 passage of the Food and Drug Administration Amendments Act (FDAAA), FDA has not previously exercised its clinicaltrials.gov enforcement authority.
The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve.
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
The US Nuclear Regulatory Commission (NRC) and state agencies oversee the possession and use of radiopharmaceuticals and medical devices containing radioisotopes. In this regard, the NRC recently issued two information notices in response to medical events arising from the administration of radiopharmaceuticals.
The Administration for Market Regulation of Jing’an District in Shanghai (AMR) on May 7 announced an administrative penalty decision against the Shanghai branch of a multinational pharmaceutical company for speaking fees it paid to physicians.
The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy state law.
In the wake of several high-profile incidents regarding data privacy and the misuse of genetic and personal information, including the case of a Chinese scientist who attracted worldwide criticism after reportedly creating the world’s first human babies whose DNA is genetically modified
Although federal efforts on drug pricing remain at the proposal stage, recently enacted legislation in six states on drug price transparency requires pharmaceutical manufacturers to review and update their approaches to prescription drug pricing and price increases on an ongoing basis to ensure compliance with state laws.