Editorial Notes

In this section of International Journal of Drug Regulatory Affairs, the writers or editors share their opinion on ongoing topics/News from agencies. Editorials are believed to be the heart and soul of the Journal. Each and every Journal is incomplete without the editorial section. Here the editor not only shares his or her view but also criticize and appreciate the ongoing topics.

Editorial is the only section were Journal can state its own opinions and comments on the current issues/Event/News.

We further welcome the Editorial notes from Editors/Writers in IJDRA Journal. It covers summary across globe from all health Authorities and major action in the industry.

Editorial Notes

Year/Quarter Editorial Notes Download
2017 (Q1)
  • Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Centre of Excellence launch
  • FDA approves Odactra for house dust mite allergies
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 17-19 January 2017
  • EMA to set up technical group in the context of the publication of clinical data
2017 (Q2)
  • FDA allows marketing of first whole slide imaging system for digital pathology
  • FDA approves new combination treatment for acute myeloid leukemia
  • Optimising safety information for medicines in Europe throughout product lifecycle
2017 (Q3)
  • EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
  • EMA Revised guideline on first-in-human clinical trials
  • FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infection
2017 (Q4)
  • FDA awards six grants for natural history studies in rare diseases
  • FDA permits marketing of device to treat diabetic foot ulcers
  • Crysvita, a medicine for the treatment of X-linked hypophosphataemia, recommended for conditional approval by EMA
  • Improving the availability of vaccines for animals within the EU
2018 (Q1)
  • FDA approves new HIV treatment for patients who have limited treatment options
  • FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing
  • EMA surveys pharma companies on their preparedness for Brexit

 

2018 (Q2)
  • FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems
  • FDA approves a new treatment for PKU, a rare and serious genetic disease
  • EMA: Working together for people with rare and complex diseases

 

2018 (Q3)
  • EMA: Fostering medicines for children
  • EMA: New medicine for the prevention of migraine
  • FDA approves new kind of treatment for hairy cell leukemia

 

2018 (Q4)
  • FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
  • FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs; including opioids
  • EMA Regulatory Science to 2025 – launch of six-month public consultation

 

2019 (Q1)
  • First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes
  • Increased risk of blood clots in lungs and death with higher dose of Xeljanz (tofacitinib) for rheumatoid arthritis
  • FDA approves first generic Advair Diskus

 

2019 (Q2)
  • FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
  • FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
  • Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 15-16 April 2019
  • CVMP opinions on veterinary medicinal products

 

2019 (Q3)
  • FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia
  • FDA approves new treatment for refractory multiple myeloma
  • Global public meeting on draft ICH guideline on clinical trials

 

2019 (Q4)
  • FDA approves new treatment for patients with migraine
  • Statement on concerns with medical device availability due to certain sterilization facility closures
  • EMA Dialogue with Chinese authorities on medicine regulation

 

2020 (Q1)
  • FDA approves first treatment for thyroid eye disease
  • FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals
  • First treatment for acute hepatic porphyria

 

2020 (Q2)
  • Global regulators stress need for robust evidence on COVID-19 treatments
  • Guidance on regulatory requirements in the context of the COVID-19 pandemic
  • Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19

 

2020 (Q3)
  • International regulators align positions on phase 3 COVID-19 vaccine trials
  • Global regulatory workshop on COVID-19 real-world evidence and observational studies
  • EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

 

2020 (Q4)
  • Update on rolling review of AstraZeneca’s COVID-19 vaccine
  • EMA recommends first COVID-19 vaccine for authorisation in the EU
  • FDA Authorizes First Direct-to-Consumer COVID-19 Test System

 

2021 (Q1)
  • FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A
  • Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

 

2021 (Q2)
  • FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
  • FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

 

2021 (Q3)
  • FDA Draft Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials
  • FDA Draft Guideline: Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
  • Clinical Trials Information System (CTIS) Webinar: How Sponsor Organisations Can Prepare for CTIS Date: 29/07/2021 (Virtual meeting)
  • ANVISA Reviews Regulations Due to COVID Pandemic.
  • Possibility of remote inspections of bioequivalence centers
  • Notice on Soliciting Public Comments on “Technical Guidance for the Application of Biomarkers in Clinical Research and Development of Anti-tumor Drugs (Draft for Comments)"

 

2021 (Q4)