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Australian regulators on Tuesday launched a series of posters to help health providers get consumers ready for upcoming changes to drug labels. Read More
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Read More
Chinese legislators are moving forward with a new law that would create stiff fines for companies that make fake vaccines, the state’s official news service announced Monday. Read More
In January, the agency issued a draft policy guidance that would allow CDER officials to “informally recognize” voluntary consensus standards related to pharmaceutical quality. Read More