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The Association for Accessible Medicines urged the FDA to clarify its draft guidance on Drug Supply Chain Security Act (DSCSA) waivers by adding an estimated timetable for review decisions. Read More
A federal appeals court ruled a Native American tribe cannot assert sovereign immunity against inter partes reviews by the U.S. Patent and Trademark Office, in the latest ruling in a battle over Allergan’s dry-eye drug. Read More
The Pharmaceutical Care Management Association is concerned about a proposed rule that could remove safe harbor protections for pharmaceutical company rebates and significantly change how U.S. drug prices are formulated. Read More
The European Medicines Agency issued the first report on its open access policy for clinical data submitted by sponsors in their marketing applications for new drugs. Read More
The European Medicines Agency expressed “serious concerns” about drugmakers’ preparedness for the UK’s departure from the European Union in a new report. Read More
UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said in an Aug. 6 update, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More
The FDA unveiled new draft guidance on nonclinical testing of orally-inhaled drug products that contain nicotine — and Commissioner Scott Gottlieb said the agency plans to release follow-up guidelines later this year on potentially clinically relevant outcomes. Read More
FDA Commissioner Scott Gottlieb said the agency will consider allowing imports of some drugs that have seen major price increases in the United States. Read More
The FDA released an updated version of its 2013 Manual of Policies and Procedures (MAPP) outlining CDER’s procedures for determining pharmacologic classes for use in prescribing information for drugs. Read More
Biosimilar sponsors need to include the name of the reference product in labeling if the label includes clinical data derived from that product, the FDA said in a final guidance. Read More
FDA Commissioner Scott Gottlieb announced the release of a new action plan for biosimilars and said it would help prime the “anemic” biosimilar market. Read More