The Congressional Budget Office (CBO) estimates bipartisan legislation designed to speed generic drugs to market could save the federal government as much as $3.3 billion. Source: Drug Industry Daily

The FDA cited Brazilian OTC drugmaker Pietrobon for multiple violations including testing and equipment problems and poor recordkeeping. Source: Drug Industry Daily

FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Source: Drug Industry…

The EMA expanded its investigation of valsartan impurities after a new contaminant was discovered in an Indian manufacturer’s active substance, losartan. Source: Drug Industry Daily

Claims that Allergan repeatedly tried to delay Restasis generics from entering the U.S. market are plausible, a U.S. District Judge ruled on Tuesday, shooting down the pharmaceutical giant’s attempts to…

An FDA advisory panel voted unanimously Thursday to recommend that the agency establish patient-focused dissolution standards for extended-release solid oral dosage forms. Source: Drug Industry Daily

Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in draft guidance issued Thursday. Source: Drug Industry Daily

The Securities and Exchange Commission (SEC) Tuesday levied a $20.8 million fine against biopharmaceutical company Clovis Oncology and two company executives for concealing the true efficacy rate of its lung…

California’s Department of Insurance filed suit against AbbVie Tuesday alleging the company increased Humira prescriptions through kickbacks and paid nurses to push patients to refill prescriptions. Source: Drug Industry Daily

The FDA Wednesday issued guidance on labeling and safety testing for heparin-containing combination products, finalizing the agency’s 2015 draft. Source: Drug Industry Daily