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Drugmakers who redact commercially confidential information from clinical study reports in Europe will have to justify their actions, says a spokesman for the European Medicines Agency, explaining what categories of confidential information the redacted data fall under. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than is provided in a related House bill. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. Read More
The FDA has approved Japanese drugmaker Takeda Pharmaceutical’s biologic injection Entyvio to treat adults with moderate to severe ulcerative colitis or Crohn’s disease. Read More
Drugmakers are asking the FDA to create separate submission requirements for NDAs, ANDAs and BLAs to demonstrate analytical procedures and methods-validation data is adequate to support the drug and biologic products. Read More
Senate lawmakers want to give the FDA $2.588 billion in discretionary funds in the next fiscal year, a $36 million boost over current levels and $13 million more than a related House bill. Read More
Manufacturers of biosimilars need to demonstrate exactly how their products compare with the reference drugs as they design clinical trials, including by paying particular attention to assessments of exposure and effects of the product on the body, according to new FDA draft guidance on creating versions of the complex therapies. Read More
Proposed copyright requirements in a recent draft of the European Medicines Agency’s clinical trial data transparency policy run counter to EMA’s moves toward greater openness, researchers argue. Read More
House lawmakers want to give the FDA a $23 million increase in discretionary funds next fiscal year, but would restrict access to certain funds in a bid to prod the agency to finalize guidance on abuse-deterrent properties for opioids. Read More