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The FDA gives advice for in vitro testing and labeling of oral drugs intended to be given by enteral tube in a draft guidance released yesterday, noting that in vitro testing prior to clinical studies will help identify any product-specific risks. Read More
At the behest of Congress, the Federal Trade Commission (FTC) has issued a report on a drug industry tactic that involves leveraging rebates to block competing products, suggesting that the agency may be viewing the anticompetitive practice as a growing area of concern. Read More
The agency noted that it is illegal to advertise that a drug can treat a disease unless it is approved based on “competent and reliable scientific evidence,” but no such study is currently known to exist for the products in question. Read More
Moderna has begun its bid for full U.S. approval for its COVID-19 vaccine in the hopes of advancing it beyond Emergency Use Authorization (EUA) status. If regulators grant the request, it will allow the company to market the vaccine directly to consumers and would mark Moderna’s first approved product for the coronavirus. Read More
World Trade Organization (WTO) negotiations resumed Monday over a revised version of a controversial proposal to temporarily waive patents for COVID-19 products, including vaccines and therapeutics. Read More
The Biden administration has asked a federal court to dismiss a PhRMA lawsuit that seeks to block authorization of a Canadian drug importation plan conducted at the state level. Read More
A trio of trade associations representing cell and gene therapy developers are urging the European Commission (EC) to permanently exempt their member state companies’ products from genetically modified organism (GMO) legislation in the EU. Read More
The Government Accountability Office (GAO), in a letter to the HHS secretary, has reiterated that the agency needs to continue to prioritize its inspections backlog. Read More
The FDA noted that agency officials will conduct a “stringent evaluation of product quality,” which includes determining whether manufacturing plants meet appropriate standards. Read More
Pharmaceutical experts sitting on advisory committees in the U.S. and UK aren’t required to disclose conflicts of interest dating back more than a year and differing public disclosure standards among entities can cause important industry ties to go unreported to the public, according to The BMJ. Read More
Provention Bio’s teplizumab, a monoclonal antibody the FDA is reviewing for delaying or preventing type 1 diabetes, should be approved because the benefits outweigh the risks, a divided Endocrinologic and Metabolic Drugs Advisory Committee said Thursday in a 10-7 vote. Read More