A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury. Source: Drug Industry Daily

The FDA hit Canadian drug distributor CanaRx with a warning letter, citing the company for supplying unapproved versions of FDA-cleared drugs. Source: Drug Industry Daily

The FDA’s Office of Generic Drugs released its annual report for 2018, highlighting a steady increase in first-time generic approvals and the green lighting of more than 1,000 generic drugs.…

The FDA issued a warning letter to an OTC drug manufacturer in Catalonia, Spain, for inadequate testing of released drug products and incomplete batch records. Source: Drug Industry Daily

The U.S. Court of Appeals for the Third Circuit upheld a Delaware federal district court’s decision to throw out an FTC lawsuit that sought to curb alleged misuse of citizen…

Novartis is hinting that it will appeal a New Jersey jury’s verdict awarding $1.5 million to a former executive who alleged that the company created a bogus drug study to…

The FDA hit Hangzhou Guogang Touring Commodity, an OTC drug manufacturer in Zhejiang, China, with a warning letter, for significant problems with equipment cleaning and drug product conformity. Source: Drug…

The FDA issued revised guidance on electronic submissions of drug master files, extending the timetable for Type III submissions by another year to May 5, 2020. Source: Drug Industry Daily

Competition is the key to lower drug costs, the Pharmaceutical Care Management Association (PCMA) said in a letter to lawmakers in defense of pharmacy benefit managers. Source: Drug Industry Daily

Drugmakers were conspicuously absent on Tuesday from two drug pricing hearings on Capitol Hill, where lawmakers called out big pharma for setting high drug prices through manipulative means — and…