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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Boehringer Ingelheim suggested the FDA draft guidance on child resistant packaging labeling, published in August, could confuse consumers who may not understand why only some drug products bear the CRP statement.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The FDA has revised its draft guidance on content and formatting for Risk Evaluation and Mitigation Strategy documents to highlight who is responsible for each required action, rather than just the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
A libertarian advocacy group that backs right-to-try laws pressed the FDA in federal court to release information about the agency’s “incredibly expeditious” decision to authorize the treatment of two Ebola patients with an unapproved drug. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the November launch of its new EudraVigilance drug safety reporting program. Read More
FDA Commissioner Scott Gottlieb will deliver a keynote address Nov. 8 at a public FTC workshop in Washington on competition in prescription drug markets. Read More