difference between 351(a) vs. 351(k) pathway

Recent Articles

• Gilead’s Voluntary Licensing Agreements for Remdesivir with 5 generic companies
• Market Exclusivity Case Study: XIFAXAN (rifaximin)
• FDA Grants Accelerated Approval to Capmatinib for NSCLC
• Aleor Dermaceuticals receives EIR from US FDA for Karakhadi formulation facility
• Lupin introduces ‘Jan Kovid’ helpline for Mumbai citizens
• Bausch + Lomb – Stada Arzneimittel – Xbrane Biopharma – licensing deal for Lucentis biosimilar
• Valneva And Pfizer to Co-Develop and Commercialize Lyme Disease Vaccine, Vla15
• Ipsen agreement with IRICoR & Université de Montréal to acquire exclusive license for discovery-stage oncology programme
• Global Licensing Agreement Case study: ProThera Biologics and Takeda to Develop Novel Plasma-Derived Therapy Based on Inter-alpha Inhibitor Proteins (IAIP)
• Glenmark Foundation rolls out tele-health solution to expand access to quality patient care
• Florio GmbH introducing new digital platform aiming to improve the lives of people with haemophilia
• Gilead Sciences, Second Genome ink collaboration strategic deal in biomarker and inflammatory bowel disease drug discovery
• Who determines when a prescription medicine should be switched to OTC status?
• What is the difference between purity and potency?
• Case Study: US FDA approves erythroid maturation agent, Reblozyl
• Case Study: Compassionate use of remdesivir of Gilead for COVID-19
• Licensing Deal Case Study: Eisai, Seikagaku co-develop & market osteoarthritis drug, SI-613 in China
• Medical Devices Regulation Update – India : All medical devices will be treated as drugs from 1st of April, 2020. Learn the implication.
• Evox partnership with Takeda Pharmaceutical for rare disease
• What are the difference between FDA 483 and Warning Letter?