• Identification of Medicinal Products (IDMP) Standards Part 3: Steps to Prepare for IDMP Implementation

    26 April 2017

    Read More

EMA Adds Five Therapies to PRIME Scheme, Bringing Total to 25

26 May 2017

Read More

European Commission: Cranberry Products Are Not Medical Devices

26 May 2017

Read More

Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 2017)

26 May 2017

Read More

FDA, EMA and PMDA Seek Antimicrobial Clinical Study Regulation Harmonization

26 May 2017

Read More

FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote

25 May 2017

Read More

Navigating the Medical Device User Fee Act (MDUFA)

25 May 2017

Read More

Copaxone Generics: Who Will Win First Filer Exclusivity?

25 May 2017

Read More

Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming

25 May 2017

Read More

Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug; Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 2017)

25 May 2017

Read More

European Regulatory Roundup: Merck Accused of Blocking Remicade Biosimilars (25 May 2017)

25 May 2017

Read More