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Competition and consolidation tied for first place on the list along with intellectual property issues, the ability to commercialize products, and litigation. Read More
Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP statement. Prescription drugs are often repackaged by dispensers or pharmacists, running the risk of the information never reaching the consumer, Boehringer said. Read More
The FDA has formalized its guidelines for sponsors seeking reconsideration of scientific or regulatory issues early in the approval process for generic drugs, issuing a guidance that also affirms the agency’s response-time pledges. Read More
The FDA has revised its draft guidance on content and formatting for Risk Evaluation and Mitigation Strategy documents to highlight who is responsible for each required action, rather than just the listing the statutory elements from the Food and Drug Administration Amendments Act of 2007. Read More
Healthcare providers strongly endorsed the 340B program that supplies them with drugs at discount, telling members of a House committee that it’s essential for supporting outreach to underserved communities. Read More
As provided for by the Biologics Price Competition and Innovation Act of 2009, Amgen and Genentech exchanged information about Mvasi and Genentech’s Avastin patents. Read More