Industry News
FDA Issues Warning Letter to Drug Compounder
FDA warns an Arkansas compounding company that it is in violation of the FDCA.
FDA and Manufacturers Map Out PDUFA Reform Priorities
A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.
FDA Reviews Drug Development
FDA releases a report that analyses why some diseases are lacking treatment options.
FDA and EU Regulators Strategize Future Collaboration
The EMA, FDA, and EC met to plan collaboration on pharmaceutical drug development and evaluation.
EMA Releases API Bioequivalence Studies Guidance
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
Experts Join CPhI Panel
Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.
Faculty and Student Research Cited by AAPS Foundation
AAPS Foundation announces 2015 new investigator grant and graduate student fellowship winners.
Agilent Technologies and the Bioprocessing Technology Institute Partner on Glycan Analysis Initiative
The collaboration will address the need for novel analytical approaches for the characterization of glycans.
Neurological Disorders Drug Development Pipeline has 420 Candidates, Says New Report
A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.
EMA Clarifies HPV Vaccine Safety Profile
The European Medicines Agency reviews the safety of human papillomavirus vaccines.
ICH Moves Genotoxic Impurities Guideline to Consultation
The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.
FDA Delays Product Tracing Requirements for Dispensers
The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.
USP Stresses Pharmacopeial Standards at CPhI China
The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.
ICH Appoints New Director of the ICH Secretariat
The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.
BioPlan Associates Releases New Report
The 12th Annual Report and Survey of Biomanufacturing is now available.
Pharmacy Associations Ask FDA to Delay Track-and-Trace Requirements
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
FDA Issues Guidance on Allowable Excess Volume for Injectables
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
European Pharmacopoeia Commission Updates Ph.Eur.
The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.
FDA Fights Online Counterfeit Drugs
The agency takes action against websites that illegally sell unapproved medications.
ICH Moves Q7 Q&A Guideline on APIs to Implementation Stage
The International Conference on Harmonization finalizes Q&A document on APIs.
NIH Outlines Corrective Action for Sterile Manufacturing Facility
NIH provides an interim corrective action plan to correct deficiencies found in its Clinical Center Pharmaceutical Development Section.
R&D Pipeline Value Jumps 18% to $493 Billion
EvaluatePharma report shows continued pharma and biotech sector confidence.
FDA Launches New REMS Website
The agency streamlines risk and mitigation information.
Continuous Manufacturing Shines at BIO
BIO to Add Innovation to Name
The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.
EMA Creates Pediatric Drug Pilot Project
The agency launches initiative to stimulate pediatric drug development.
CPhI Adds Biologics Development Innovation Award
CPhI Worldwide announces five new categories for the 2015 CPhI Pharma Awards.
FDA Releases Guidance on Treatment for Duchenne Muscular Dystrophy
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
FDA Guidance Seeks More Effective Postapproval Change Strategies
FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
Amgen and Sandoz: Battle Over Neupogen Biosimilar “Shall” Continue
