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EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews

EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews

Jan 15, 2021 | News, Regulatory

The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use...
Medtronic Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients

Medtronic Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients

Jan 14, 2021 | News, Regulatory

Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe...
The European Commission Announces Acceptance of Remote Audits Amidst COVID-19

The European Commission Announces Acceptance of Remote Audits Amidst COVID-19

Jan 13, 2021 | News, Regulatory

The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
EMA Grants Orphan Drug Designation for NeuroSense Therapeutic’s ALS Drug Therapy

EMA Grants Orphan Drug Designation for NeuroSense Therapeutic’s ALS Drug Therapy

Jan 12, 2021 | News, Regulatory

The European Medical Association (EMA) granted NeuroSense Therapeutics, a clinical stage drug development company, orphan drug designation today (1/12) for PrimeC, a unique combination drug for treatment of Amyotrophic Lateral Sclerosis (ALS). The U.S. Food and Drug...
Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs

Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs

Jan 11, 2021 | News, Regulatory

Abbott Laboratories, a multinational health care and medical device company, announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA), making history as the first ever handheld blood test for traumatic brain injuries (TBIs). The...
The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance

The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance

Jan 8, 2021 | News, Regulatory

On Wednesday (1/6) the U.S. Food and Drug Administration (FDA) announced that it is tracking the COVID-19 testing diagnostics with SARS-CoV-2 test developers to determine the efficacy of the already-approved tests on their ability to detect new COVID-19 variants. The...
FDA Grants Fast Track Designation for Gemini Therapeutics’ Treatment GEM103

FDA Grants Fast Track Designation for Gemini Therapeutics’ Treatment GEM103

Jan 7, 2021 | News, Regulatory

Today (1/7) Gemini Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted GEM103 treatment of dry age-related macular degeneration (AMD) for Fast Track designation. Gemini Therapeutics is a clinical stage precision medicine company based in...
The Diversity of India and Its Impact on the Global Clinical Trial Landscape

The Diversity of India and Its Impact on the Global Clinical Trial Landscape

Jan 7, 2021 | Clinical Trials, Language Service Provider, Medical Translation, Pharmaceuticals, Regulatory

With a population of more than 1.3 billion people, India is one of the fastest growing economies in the world. As their global economy continues to expand, and as clinical trials are continuing to be conducted overseas, India remains unique in both the opportunities...
FDA Releases Statement Urging Healthcare Providers to Follow Proper Dosing Schedules

FDA Releases Statement Urging Healthcare Providers to Follow Proper Dosing Schedules

Jan 6, 2021 | News, Regulatory

The U.S. Food and Drug Administration (FDA) released a statement on Monday (1/4) urging healthcare providers to follow the approved dosing schedules for COVID-19 vaccinations, after discussions of changing doses, limiting doses, and extending length of time in between...
FDA Clears BioSerenity’s Electroencephalography (EEG) Wearable Device

FDA Clears BioSerenity’s Electroencephalography (EEG) Wearable Device

Jan 5, 2021 | News, Regulatory

Today (1/5) BioSerenity announced that the U.S. Food and Drug Administration (FDA) cleared the Neuronaute® EEG System and IceCap® EEG wearable device. The device is designated for patients diagnosed with epilepsy, and will enable physicians to remotely monitor and...
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Recent Posts

  • EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews
  • Medtronic Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients
  • The European Commission Announces Acceptance of Remote Audits Amidst COVID-19
  • EMA Grants Orphan Drug Designation for NeuroSense Therapeutic’s ALS Drug Therapy
  • Abbott Laboratories Announces FDA 510(k) Clearance for Innovative Rapid Handheld Blood Test for Mild TBIs

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