What is difference between 351(a) vs. 351(k) pathway?

Recent Industry Update

• Consequences and progress of Takeda-Shire Buyout
• Indian health ministry banned 329 controversial fixed dose combination with immediate effect
• Pharma aaquisition: Aurobindo to acquire dermatology and oral solids businesses from Sandoz Inc. for $900 million
• Market Launch and brand positioning of Volini Maxx
• Grünenthal’s Duzallo: EU marketing authorization and Brand Positining
• USFDA approval of patisiran, first-of-its kind targeted RNA-based therapy
• Digital Strategy for pharma brand promotion: Merck launch map4health
• Insight on Novo Nordisk’s acquisition of Bristol, UK-based Ziylo for $800 million
• AstraZeneca’s Lynpraza got DCGI (India) marketing approval
• Pharma Packaging > How to convert IU to mg?
• Brand Promotion: Mankind’s OTC brand KABZEND
• PDL – Depomed’s deal for type 2 diabetes products
• EMA’s Prime Designation for Roche’s RG6042 – to treat Huntington’s disease
• In clinical research, is observational study is also known as interventional study?
• US FDA grants breakthrough therapy status for Lenvima in combo with Keytruda
• Insight on Bayer’s EU approval of new treatment regimen for Eylea
• Case Study: LEO Pharma’s acquisition of Bayer’s dermatology unit
• Wockhardt sets up $40-million antibiotic manufacturing plant in Jafza, Dubai
• What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?
• EMA committee recommends approval of Merck’s Keytruda in combo with pemetrexed & platinum chemotherapy to treat metastatic nonsquamous NSCLC
• Daiichi Sankyo, Glycotope to develop gatipotuzumab antibody drug conjugate
• Hyrimoz Sandoz’s biosimilar got European marketing approval
• Is COPP and FSC is same?
• Nabriva acurie Zavante to stregthen antibiotic pipeline
• US FDA committee recommends approval malaria drug, Tafenoquine
• What is EMA’s PRIME designation?
• Sun Pharma launches generic Glumetza tablets in US
• Insight on FDA Approval of Symtuza for Treatment of HIV Infection
• Case Study on USFDA Label Expansion: Novartis’ Kisqali
• Close look into US FDA 510(k) clearance – Adaptiiv’s 3D Bolus Software