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The FDA has made great strides in conducting international inspections — but still remains detrimentally understaffed, according to the government’s official watchdog, during a time when the agency has begun to inspect more sites overseas than within the U.S. Read More
The FDA handed warning letters to three drug manufacturers, citing them for GMP violations that range from data integrity deficiencies to sterility control failures. Read More
The FDA is providing industry with a list of examples of product communications, including promotional materials, consistent with the agency-approved labeling. Read More
Sponsors seeking approval for an interchangeable biosimilar should plan to conduct a switching study using a U.S.-licensed comparator product and primary endpoints that assess clinical pharmacokinetics (PK) and pharmacodynamics (PD). Read More
The FDA rejected Adapt Pharma’s request to raise the standards for the approval of naloxone generics, arguing that products will be reviewed on a case by case basis. Read More
Six generics makers are facing a civil lawsuit for allegedly colluding to fix the prices of the antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More
UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Read More
Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Read More
Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Read More
A majority of patent settlements reached last year in the European Union restricted the market entry of generics, according to a European Commission report. Read More