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The Office of Generic Drugs has taken action on more than 90 percent of its backlog of ANDAs and prior approval supplements, more than 15 months ahead of schedule, CDER Director Janet Woodcock announced Monday. Read More
Two U.S. API makers are taking heat for a host of recordkeeping failures and related issues following FDA inspections of their production facilities. Read More
The FDA has faulted two compounders for neglecting to apply quality controls to the production of their sterile drugs, pummeling one of the compounders with 13 citations. Read More
The U.S. Supreme Court has asked the solicitor general to consider if a lower court erred in mandating that Novartis wait six months after approval of a biosimilar before going to market. Read More
Even with an abundance of FDA work left undone with biosimilars, industry development activities seem unaffected, with many “extremely active” in that space, an agency official says. Read More
The second highest court in the land rejected Mylan’s requested rehearing in two patent lawsuits, leaving the company with few options for avoiding the cases. Read More