Overcoming Challenges in Fluorine-Based Chemistry
Fluorinated molecules are important as pharmaceutical compounds. Recent advances involve selective and late-stage insertion of fluorine into small molecules.

A Risk-Based Approach to Monitoring Elemental Impurities in Leachable Studies
The authors discuss a strategy for developing a risk-based approach for testing of elemental impurities in leachable studies.

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Woodcock Committed to New Drug Quality Office
Establishing a new Office of Product Quality is a top priority for Janet Woodcock, FDA’s CDER director, who plans to take charge of the operation personally.

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Video: GSK’s Big Hopes for Vaccine Development
Sophie Biernaux, VP and vaccine development leader, malaria and Joe Cohen, advisor malaria vaccine program, at GSK Vaccines at PhRMA’s Research and Hope Awards ceremony on their impact of their award-winning vaccine program.

J&J Fined $2.2 Billion for Off-label Marketing and Kickbacks
Allegations include off-label marketing for Risperdal, Invega and Natrecor and kickbacks to doctors and pharmacists.

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EMA and FDA Release QbD Guidance
EMA and FDA publish joint QbD guidance on design space verification.

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FDA Releases Report on Personalized Medicine
A new report details FDA's role and responsibilities in personalized medicine.

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FDA Takes Actions to Prevent Drug Shortages
FDA releases a strategic plan and issues a proposed notification rule to improve prevention and resolution of drug shortage problems.

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Teva CEO Steps Down
Jeremy Levin, CEO and president of Teva Pharmaceutical Industries steps down, and interim successor named.

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AstraZeneca Receives Mixed Decision on US Patent Litigation
A US court of appeals rules on patent litigation for AstraZeneca's asthma drug Pulmicort Respules (budesonide).

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