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Reaction is mixed to proposed legislation to revamp portions of the FDA’s drug approvals process, with generics makers already pushing back against a proposal to extend a drug’s patent protection if it serves unmet needs while others are praising parts of the bill that would speed up and simplify approvals. Read More
India’s medicines authority Wednesday detailed a proposed set of steps drugmakers must take to schedule presubmission screening meetings with drug reviewers — codifying an informal system that was launched several years ago. Read More
Europe’s brand and generic drugmakers are proposing a coordinated approach for regulators and industry to quickly identify and respond to drug shortages caused by manufacturing and quality issues. Read More
The House Energy & Commerce Committee that oversees the FDA is planning an overhaul of agency procedures to increase orphan drug development, streamline clinical trials oversight, give industry incentives to find new uses for old drugs and expand U.S. drug manufacturing. Read More
President Obama will ask Congress to approve more than $1.2 billion in funding — nearly double the current amount — to fuel development of new antibiotics. Read More
The White House released a joint statement by President Barack Obama and Indian Prime Minister Narenda Modi pledging to negotiate a harmonized approach to intellectual property protections and establish standard definitions for what is patentable. Read More
A new report finds growing support among pharma executives for the FDA to evaluate drug candidates on both their clinical and economic effectiveness, with 43 percent of drug company execs supporting the concept compared with 14 percent in 2010.
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The FDA emphasized flexibility in a Monday final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements. Read More
In a 46-page draft guidance released Monday, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems. Read More
Antares Pharma received an FDA complete response letter for labeling issues and minor deficiencies in its ANDA for sumatriptan injection USP, the company said in a Monday SEC filing. Read More