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The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. Read More
The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
The FDA slammed a Chinese active pharmaceutical ingredient (API) manufacturer for using a supplier of potentially contaminated heparin and for restricting access during an inspection. Read More
The Texas attorney general has sued AstraZeneca over allegations the company illegally pushed off-label uses of its antipsychotic Seroquel, a move that comes four years after AZ paid hundreds of millions of dollars to settle similar litigation nationwide. Read More
Regulators in Europe have proposed restricting access to certain information in a forthcoming clinical trials portal and database, but industry wants assurances that the system will be able to differentiate security access for different types of documents. Read More
The FDA approved Eisai’s Akynzeo to treat nausea and vomiting from chemotherapy, the latest success by the Japanese drugmaker to expand its portfolio of such products. Read More
Australian doctors and academics are asking their colleagues worldwide to ban all meetings with pharmaceutical sales reps for a year in a bid to reduce concerns over inappropriately pushed medications. Read More
The FDA has expanded market exclusivity from three to five years on all fixed-dose combination drugs that contain a new active ingredient, bowing to industry pressure for new incentives to develop the costly products. Read More