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The FDA and Customs and Border Protection (CBP) began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
The FDA is making minor changes to its recommendations for companies developing new investigational drugs to treat all types of uncomplicated gonorrhea, expanding eligibility for clinical trial participation to include subjects who are HIV-positive and adopting rapid diagnostic tests to select patients for enrollment. Read More
GPhA is stepping up its opposition to the FDA’s proposed generics labelling rule, releasing a survey that shows more than half of physicians, physician assistants and pharmacists would find the new system confusing for them and their patients. Read More
Drugmakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitations that Twitter imposes on each message, the FDA says. Read More
Two prominent generic drugmakers in Canada won a regulatory victory last month when a federal judge ruled that the country’s regulator of patented medicine prices has no jurisdiction over licensed generic drug pricing. Read More
Delaware has become the latest state to let pharmacists substitute biosimilar products for the prescribed biological reference product, a move cheered by a national biopharmaceutical trade group. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
Drugmakers submitting regulatory filings in the U.S., Europe and Japan generally may use pharmacopeia texts on dosage units interchangeably in the three regions, according to a final FDA guidance that adopts guidelines from the International Conference on Harmonization. Read More
Manufacturer Hospira’s 2005 withdrawal of its leucovorin injection was not done for effectiveness or safety reasons, the FDA said, paving the way for new ANDAs on the generic anemia drug. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel concluded last week, instead urging the agency to require postmarket observational studies. Read More