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President Barack Obama Monday signed into law H.R. 1314 that would require generics makers to pay inflation-based rebates if prices rise too quickly, based on the inflation-adjusted baseline average manufacturer price. Read More
The senators are asking the FTC to investigate whether the suppliers are taking advantage of the shortage in ways that run afoul of antitrust laws. Read More
The FDA will not be forced into a shutdown this year after the Senate passed a two-year budget early Friday morning for fiscal years 2016 and 2017. Read More
The FDA is once again giving retail and health system pharmacies that act as dispensers four months to ensure that product tracing information required by track-and-trace regulations is captured and maintained. Read More
The FTC is telling the FDA that its proposal to add four-letter suffixes to nonproprietary names for biosimilars and other biological products could be bad for business. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
Drugmakers won a victory on Monday when the Senate approved by unanimous consent an amended bill that would extend exclusivity periods for new drugs by changing the date on which they are considered to have been approved from FDA sign-off to when the DEA schedules them. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More