Most life sciences companies plan to significantly step up their use of real-world data sources over the next three years, according to a new survey by the Tufts Center for…
The FDA is working to prevent manufacturers of branded high-risk drugs from stalling an application for approval of a generic competitor via manipulation of a requirement to share safety programs,…
FDA Commissioner Scott Gottlieb once again chastised brand-name companies that slow-walk federal procedures and use regulations to delay the entry of generic competitors. Source: Drug Industry Daily
The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials. Source: Drug Industry Daily
A group of investment funds sued Allergan, accusing the company of artificially inflating its stock by conspiring with other manufacturers of generic drugs. Source: Drug Industry Daily
Federal administrators of the Medicare Part D prescription-drug program should expand their oversight of opioid prescriptions and focus their surveillance of potential drug abuse more tightly on opioids, the U.S.…
Allergan drew bipartisan fire from U.S. House members considering issues raised by the company’s innovative scheme to shield its patents on the blockbuster dry-eye drug Restasis from challenges before the…
A Stanford law professor said the president already has the authority to provide for administration of unapproved drugs to military personnel — a power similar to that proposed for the…
The FDA cited an outsourcing drug compounder in Arkansas for failure to meet sterile production standards, according to a warning letter from the agency. Source: Drug Industry Daily
A federal judge ruled against a motion by three drugmakers to shut down antitrust litigation involving the Lidoderm pain patch. Source: Drug Industry Daily