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Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support

Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.

Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.

food and drug administration
Supreme Court Nominee Draws Concern from Environmentalists
Supreme Court Nominee Draws Concern from Environmentalists
Catherine Offord | Jul 10, 2018
President Trump’s pick, Judge Brett Kavanaugh, has often opposed court involvement in environmental and health regulations.
Congress Passes “Right to Try” Bill
Congress Passes “Right to Try” Bill
Jim Daley | May 23, 2018
Medical groups have criticized the legislation, which will give terminal patients access to experimental treatments, as dangerous and unnecessary.
FDA Seeks to Block Two Unregulated Stem Cell Clinics
FDA Seeks to Block Two Unregulated Stem Cell Clinics
Jim Daley | May 11, 2018
Two patients became legally blind after receiving treatments at the facilities.
FDA Declares Kratom an Opioid. We’re Here to Explain What It Does.
FDA Declares Kratom an Opioid. We’re Here to Explain What It Does.
Jim Daley | Feb 7, 2018
The Scientist speaks with a clinical toxicologist to discuss how the supplement acts in the brain and what the agency's declaration means for research.
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Jef Akst | Oct 12, 2017
Spark Therapeutics’s Luxturna would be the first approved therapy in the U.S. that replaces or repairs a defective gene inherited from one’s parents.
Majority of Top Government Science Jobs Unfilled
Majority of Top Government Science Jobs Unfilled
Catherine Offord | Aug 31, 2017
Only 12 positions out of 44 have received nominations, and half of Trump’s nominees have strong ties to the industries they would oversee, a new report shows.
FDA to Cut Back Hiring of Non-US Citizens
FDA to Cut Back Hiring of Non-US Citizens
Shawna Williams | Aug 14, 2017
The move appears to be out of step with other HHS agencies.
New FDA Pathway to Accelerate Development of Cell Therapies
New FDA Pathway to Accelerate Development of Cell Therapies
Jef Akst | May 22, 2017
Four products have already qualified for the regenerative medicine advanced therapy (RMAT) designation that provides extra interactions with the agency, and sooner.
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
John D. Loike and Jennifer Miller | Feb 1, 2017
What can be done to lower development costs and drug prices?