Food and Drug Administration

Health Policy & Law Daily News Service - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 6, 2020
Legal, Professional services, Health, Other Health, Health, Pharmaceuticals policy, Food and Drug Administration, Pharmaceutical industry, Medical device, Pharmac

The "Health Policy & Law Daily" newsletter has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Health Policy & Law Daily" newsletter has been added to ResearchAndMarkets.com's offering.
  • Health Policy & Law Daily focuses on the latest news and regulatory developments from the FDA and U.S. government concerning food products, medical devices, pharmaceuticals, biotechnology, medical practice, hospitals, and more.
  • Legal counsel, physicians, and health professionals can also learn about ongoing lawsuits, contract negotiations, and settlements in the health, medical, and pharmaceutical fields.
  • For over 30 years, the analyst has monitored and reported on the world's emerging research and discoveries every day.

AMAG Pharmaceuticals Provides Update on FDA’s Proposal Regarding Makena® (Hydroxyprogesterone Caproate Injection)

Retrieved on: 
Tuesday, October 6, 2020
Brand management, Product management, AMAG Pharmaceuticals, AMAG, Food and Drug Administration, Marketing, Trademark, Pharmaceutical industry in China, Health

The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal.

Key Points: 
  • The FDA in its letter also notified AMAG that the company has the opportunity to request a hearing on the withdrawal.
  • The company has 15 days to respond to the FDA indicating whether AMAG would like to proceed with a hearing.
  • This process can take months and during this time Makena and the approved generics of Makena will remain on the market, according to the FDA.
  • AMAG Pharmaceuticals, the logo and designs, are registered trademarks ofAMAG Pharmaceuticals, Inc. Makenais a registered trademark ofAMAG Pharma USA, Inc.

FDA, Mexican Counterparts Enhance Food Safety Partnership

Retrieved on: 
Monday, October 5, 2020
Food and Drug Administration, Articles, United States Public Health Service, Health, Food safety, Food and drink, Michael R. Taylor

This Statement of Intent broadens and strengthens the scope of their existing partnership to include the safety of all human food regulated by the FDA.

Key Points: 
  • This Statement of Intent broadens and strengthens the scope of their existing partnership to include the safety of all human food regulated by the FDA.
  • Our enhanced food safety partnership with our Mexican colleagues will play an important role in helping each country's respective efforts to create a modernized food safety regulatory framework," said FDA Commissioner Stephen M. Hahn, M.D.
  • "The New Era of Smarter Food Safety Blueprint outlines the approach the FDA will take over the next decade to encourage more effective and modern food safety processes," said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.
  • This modern approach to food safety utilizes all available tools and technologies to help ensure a strong and resilient food system.

CLEANLIFE® Makes Donations of PPE to Support Community, Maintain Awareness

Retrieved on: 
Monday, October 5, 2020
Food and Drug Administration, United States Public Health Service

Founder and CEO of CLEANLIFE, Justin Miller, reminds us that "a lot of attention was placed on frontline workers at the beginning of the pandemic.

Key Points: 
  • Founder and CEO of CLEANLIFE, Justin Miller, reminds us that "a lot of attention was placed on frontline workers at the beginning of the pandemic.
  • Earlier this summer, CLEANLIFE made donations to the Norma Herr Women's Shelter and the Zelma George Family Center located in Cleveland.
  • CLEANLIFE got involved with PPE when the pandemic first hit in China.
  • CLEANLIFE LLC is an FDA registered importer and distributor of PPE (FDA Registration #3014404166).

Patient Power® COVID Cancer Patient Survey Shows Most Cancer Patients Willing to Take Part in Clinical Trials Despite Coronavirus

Retrieved on: 
Monday, October 5, 2020
Health, Pharmaceutical industry, Articles, Clinical research, Drug discovery, Food and Drug Administration, Clinical trial, Design of experiments, Patient participation, UK Coronavirus Cancer Monitoring Project

CARLSBAD, Calif., Oct. 5, 2020 /PRNewswire/ -- Patient Power, a patient-driven cancer news organization, reports that a majority of cancer patients still want to participate in cancer treatment clinical trials despite the COVID-19 pandemic, according to a recent survey of 1,485 cancer patients.

Key Points: 
  • CARLSBAD, Calif., Oct. 5, 2020 /PRNewswire/ -- Patient Power, a patient-driven cancer news organization, reports that a majority of cancer patients still want to participate in cancer treatment clinical trials despite the COVID-19 pandemic, according to a recent survey of 1,485 cancer patients.
  • The Patient Power COVID-19 Cancer Trial Survey, the second Patient Power survey on how cancer patients feel about clinical trials, also showed that patients are willing to take part in trials even if it means coming into clinical settings frequently during the coronavirus pandemic.
  • The Patient Power COVID-19 Cancer Trial Survey also had twice the number of respondents than the earlier, pre-pandemic survey.
  • "This survey shows that most cancer patients are still willing to participate in clinical trials, despite the very real dangers the pandemic poses to them," said Andrew Schorr, Patient Power Co-Founder and President.

Senseonics Submits PMA Application for 180-Day Eversense System to the FDA

Retrieved on: 
Monday, October 5, 2020
FDA, Diabetes, Medical devices, Health, Medical Supplies, Medical technology, Medicine, Continuous glucose monitor, Pharmaceutical industry, Diabetes, Medical monitoring, Food and Drug Administration, Minimed Paradigm

The PMA application is supported by clinical data generated from the PROMISE Clinical Study.

Key Points: 
  • The PMA application is supported by clinical data generated from the PROMISE Clinical Study.
  • If the 180-day Eversense product is approved by the FDA, Senseonics partner Ascensia Diabetes Care will initiate sales in the United States.
  • A decision on approval of the 180-day Eversense System is anticipated during the first half of next year.
  • Senseonics' CGM systems, Eversense and Eversense XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor.

AIR FACTORY® PMTA Acceptance Letter Received

Retrieved on: 
Friday, October 2, 2020
Wine & Spirits, Health, Tobacco, FDA, Convenience store, Food, Beverage, Online Retail, Retail, Psychoactive drugs, Tobacco, Electronic cigarettes, Smoking, Smoking cessation, Food and Drug Administration, Tobacco control, Electronic cigarette, Premarket tobacco application, Nicotine

My Vape Order, Inc. (MVO) today received the much-anticipated Acceptance letter from U.S. Food and Drug Administration (FDA) for its bundled AIR FACTORY Premarket Tobacco Application (PMTA).

Key Points: 
  • My Vape Order, Inc. (MVO) today received the much-anticipated Acceptance letter from U.S. Food and Drug Administration (FDA) for its bundled AIR FACTORY Premarket Tobacco Application (PMTA).
  • Receipt of FDAs Acceptance letter confirms that the AIR FACTORY PMTA meets the statutory and regulatory requirements for a PMTA submission and signals that the PMTA is now in FDAs Filing Review, or preliminary scientific review, phase.
  • MVO looks forward to working with FDA on its review of the AIR FACTORY PMTA, which covers a suite of 72 AIR FACTORY products, including both freebase and salt nicotine formulations in a variety of nicotine strengths tailored to meet the needs of our AIR FACTORY consumers.
  • We will continue to provide AIR FACTORY PMTA and product updates at www.airfactoryeliquid.com .

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of BioMarin Pharmaceuticals Inc. (BMRN) on Behalf of Investors

Retrieved on: 
Friday, October 2, 2020
Banking, Professional services, Health, Life sciences, BioMarin Pharmaceutical, Virotherapy, Medication, Food and Drug Administration, Orphan drugs, Sanofi

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased BioMarin Pharmaceuticals Inc. (BioMarin or the Company) (NASDAQ: BMRN ) securities between February 28, 2020 and August 18, 2020 (the Class Period).

Key Points: 
  • Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased BioMarin Pharmaceuticals Inc. (BioMarin or the Company) (NASDAQ: BMRN ) securities between February 28, 2020 and August 18, 2020 (the Class Period).
  • BioMarin investors have until November 24, 2020 to file a lead plaintiff motion.
  • As a result, the FDA recommended that BioMarin complete the Phase 3 Study and submit two-year follow-up safety and efficacy data on all study participants.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin for the Treatment of COVID-19

Retrieved on: 
Friday, October 2, 2020
Health, Medicine, Articles, Antivirals, Occupational safety and health, Coronavirus disease, Zoonoses, Coronavir, Food and Drug Administration, COVID-19 drug development, COVID-19 drug repurposing research

The request for the pre-IND meeting follows the FDA guidance issued in May 2020, COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.

Key Points: 
  • The request for the pre-IND meeting follows the FDA guidance issued in May 2020, COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products.
  • Confirmation of the meeting being granted by FDA, with return of written responses, has been received.
  • Extensive pre-clinical research, nearing completion, conducted at independent laboratories reinforces the antiviral potential of Brilacidin against SARS-CoV-2, the novel coronavirus responsible for COVID-19.
  • Numerous hospitals and provider networks domestically and abroad have expressed a strong interest in participating in the Brilacidin for COVID-19 clinical trial.

PharmaCyte Biotech’s Investigational New Drug Application Placed on Hold by the U.S. FDA

Retrieved on: 
Friday, October 2, 2020
Oncology, FDA, Health, Diabetes, Pharmaceutical, Biotechnology, Food and Drug Administration, Health, Articles, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Form FDA 483

The FDA will issue an official hold letter within the next 30 days with written details identifying the reason(s) that FDA examiners issued the hold.

Key Points: 
  • The FDA will issue an official hold letter within the next 30 days with written details identifying the reason(s) that FDA examiners issued the hold.
  • Once PharmaCyte has the official letter it can address all of the identified reasons for the hold.
  • Then, PharmaCyte will file a response to the official letter from the FDA.
  • The FDA will have another 30 days to review the material submitted by PharmaCyte and decide whether to lift the hold.