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Applications for generics of Johnson & Johnson’s Risperdal should contain characterization data on the reference product and the copycat version, the FDA says. Read More
In a move that may hinder companies looking to develop generic Tyvaso, the combination product’s developer is asking the FDA to impose stringent approval requirements on generic competitors. Read More
Drugmakers seeking approval of fidaxomicin generics to treat Clostridium difficile-associated diarrhea have two options for demonstrating bioequivalence, the FDA said. Read More
To shed light on the regulatory requirements for the development of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
Drugmakers submitting ANDAs for new drug strengths face FDA refusals due to insufficient justifications for impurities in the products, the agency says. Read More
The FDA cited a pharmaceutical firm for a range of GMP violations, firing off a warning letter over issues ranging from data integrity to risk management. Read More
Sentara Enterprises has received a letter from the FDA after an inspection of its facility in response to information from the Virginia Department of Health on two cases of illness in pediatric patients who were given Sentara products. Read More
The Bangladesh High Court has targeted 34 drug firms for ignoring an earlier ban on their products, demanding that they immediately recall their products. Read More