Articles

• Qualifying your cleanroom

  Revised GMP guidelines will strengthen emphasis on contamination control, impacting cleanroom performance qualifications

• Enhancing the Paragraph IV Patent Certifications List database

  FDA looks to improve transparency and predictability for generic drug applicants

• CDMO trends: Drug development and industry consolidation

  How those in the outsourcing sector can be more prepared to meet shifting customer demands as the industry continues to evolve.

• FDA DSCSA Pilot Project Program

  A question and answer with John Jacey, a leader on TraceLink’s Digitalization Strategy team