Envisioning the Dual Repercussions of FDA’s Accelerated Approval Pathway

1

• Envisioning the Dual Repercussions of FDAs
  Accelerated Approval Pathway
• Clinical trials are comprehensive research
  studies conducted to ensure that recently
  developed medical interventions, including novel
  drugs, surgical other devices, and treatments/
  therapies, are safe and effective for human use
  before commercialization. These trials provide
  evidence for regulatory bodies like the US Food
  and Drug Administration (FDA), European Medicines
  Agency (EMA), Health Canada, UKs Medicines and
  Healthcare Products Regulatory Agency, and
  Chinas National Medical Products Administration
  (NMPA) to ensure that a specific medical
  intervention is safe for the public use, begets
  limited adverse effects, and meets quality
  standards. However, it takes 10 to 15 years or
  even more to complete all three clinical trial
  phases before reaching the licensing stage.
  Thus, FDA introduced accelerated or expedite
  approvals to pace up the approval of drugs that
  treat severe conditions and address unmet medical
  needs.
• Before proceeding with the pros and cons of the
  FDAs expedited program, lets first understand
  the full-fledged approval process set by various
  regulatory agencies to launch any novel medical
  interventions in the market after comprehensive
  analysis.
• Pre-Approval the regulatory agencies set
  specific guidelines around study design,
  volunteer selection, monitoring procedures,
  informed consent, and data collection, which
  pharmaceutical industries must adhere to when
  conducting clinical trials.
• Investigational New Drug (IND) Application
  Drugmakers/ sponsors are obliged to submit an
  IND application to the regulatory body before
  initiating a clinical trial. This application
  comprises justification, proposed study design,
  safety data from pre-clinical studies, and a
  feasible approach to monitor volunteers during
  the trial.
• Review Process The regulatory agency thoroughly
  reviews the statistical data, data quality,
  results of all phases of pre-clinical and
  clinical trials, and potential benefits risks
  associated with the particular intervention.
• Post-Approval Even after granting approval for
  marketing and commercializing medical
  interventions, the regulatory body continues to
  monitor the safety and efficacy of approved
  products through post-marketing surveillance and
  requires periodic reporting of adverse events.
• Need for introducing USFDA Accelerated Approval
  Program
• The US FDAs Accelerated Approval Program (AAP)
  aims to expedite the development and enable
  faster access to new therapies that address an
  unmet need in treating severe
• ailments. This program is mainly introduced to
  promote the treatment of chronic diseases, where
  the course of the condition is extended, and
  determining the clinical endpoint would take
  considerable time. The primary objective behind
  introducing a priority review of
• specific drugs for accelerated approval is to
  launch the drugs earlier in the market. To
  justify, in the case of chronic diseases like
  HIV and cancer, thoroughly understanding the
  effect of medications with precision can take a
  long time, which results in delayed drug approval.

2
Click below to read the complete article by
IEBS_at_ https//www.iebrain.com/dual-repercussions
-of-fdas-accelerated-approval-pathway/ About
Ingenious e-Brain Solutions - Ingenious e-Brain
Solutions provides high-quality, customized, and
cost-effective Technology Intelligence, Business
Intelligence, and Intellectual Property
Intelligence solutions to industry leaders, and
innovative companies across the globe.
Innovation, knowledge, and transparency form the
basis of our companys mission and vision. Along
with cost benefits, we provide highest quality
results ensuring fool-proof confidentiality and
security. We are an ISO certified company with
offices in India and USA. Ingenious e-Brain
Solutions has a strong team of analysts, and
subject matter experts with domain proficiency
which is devoted to help clients grow. Our highly
qualified professionals offer tailored,
value-added and cost-effective services to our
clients. We believe in building long term
relationships with our clients who include
national and international corporations, Fortune
500 companies, worlds leading research
institutes and universities as well as
independent inventors. Get in Touch - India
Office 207-208 Welldone TechPark, Sohna Road
Sector 48, Gurugram, Haryana 122018, India 91
124 429 4218 Email - queries_at_iebrain.com