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Responding to more than a dozen Form 483 responses from compounders that say they’re not subject to FDA GMP requirements, the agency put compounders on notice outlining enforcement penalties and bulk substance rules that compounders must adhere to. Read More
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