Commissioner of Food and Drugs

Food Allergy Advocacy Sends Petition with First 20,000 Signatures to FDA and Congress Demanding Approval of Nasal Epinephrine

Retrieved on: 
Giovedì, Ottobre 12, 2023

NEW YORK, Oct. 12, 2023 /PRNewswire/ -- SnackSafely.com — a leading food allergy advocacy established in 2011 — sent a petition with over 20,000 signatures to the FDA and oversight committees in Congress, demanding approval of nasal epinephrine for use in anaphylactic emergencies.

Key Points: 
  • NEW YORK, Oct. 12, 2023 /PRNewswire/ -- SnackSafely.com — a leading food allergy advocacy established in 2011 — sent a petition with over 20,000 signatures to the FDA and oversight committees in Congress, demanding approval of nasal epinephrine for use in anaphylactic emergencies.
  • Anaphylaxis is a life-threatening allergic reaction to a food, drug, insect venom, or environmental substance.
  • Epinephrine is the only drug that can halt and reverse the progression of anaphylaxis, but it must be administered promptly to be effective.
  • Furthermore, the FDA's own advisory panel voted 17-5 to approve a nasal epinephrine candidate for children and 16-6 for adults in May of 2023.

"GET THE F OUT OF THE FDA": Marler Clark Calls for the Reorganization of the FDA, Distributes 1,000 T-shirts to the Food Safety Summit and FDA Officials

Retrieved on: 
Martedì, Maggio 9, 2023

Marler Clark sent free t-shirts to over 750 people as well as hand delivering 250 of these t-shirts to Congressional leaders in Washington DC.

Key Points: 
  • Marler Clark sent free t-shirts to over 750 people as well as hand delivering 250 of these t-shirts to Congressional leaders in Washington DC.
  • "Each year, millions of Americans are sickened, and thousands die from foodborne illness," said Bill Marler.
  • "And yet, the leadership of the FDA continues to be preoccupied with drug oversight and to give short shrift to food safety."
  • "We need to separate the FDA functions between Food (food safety and human nutrition) and Drugs (and medical devices).

Covis Statement on FDA Decision to Withdraw Approval of Makena®

Retrieved on: 
Venerdì, Aprile 7, 2023

The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implement the withdrawal.

Key Points: 
  • The decision from the FDA Commissioner and Chief Scientist deferred to the Center for Drug Evaluation and Research (CDER) to determine next steps to implement the withdrawal.
  • The company recommends that healthcare providers consider FDA’s conclusion on the withdrawal of Makena.
  • As detailed previously , shortly following the 2022 public hearing, Covis requested an orderly wind-down in an effort to voluntarily withdraw Makena.
  • Patients who have questions are encouraged to speak with their healthcare providers, or call 1-800-847-3418, Monday–Friday from 8:00 AM–8:00 PM ET.

FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena

Retrieved on: 
Giovedì, Aprile 6, 2023

The decision was issued jointly by the FDA Commissioner and Chief Scientist.

Key Points: 
  • The decision was issued jointly by the FDA Commissioner and Chief Scientist.
  • Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce.
  • Based on that review, they have decided to withdraw approval of Makena and generic versions of Makena.
  • The decision issued today by the FDA Commissioner and Chief Scientist outlines their rationale and also recognizes the crucial need to develop treatments to reduce the serious risks associated with preterm birth.

Covis Pharma Responds to Presiding Officer’s Report Summarizing FDA Advisory Committee Hearing

Retrieved on: 
Martedì, Marzo 7, 2023

ZUG, Switzerland, March 07, 2023 (GLOBE NEWSWIRE) -- Covis Pharma Group (“Covis”), today announced it has submitted a response to the Presiding Officer’s report summarizing the October 17-19, 2022 public hearing and providing recommendations on the Center for Drug Evaluation and Research’s (CDER) proposal to withdrawal approval for Makena® (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.

Key Points: 
  • Covis appreciates the opportunity it was afforded to present its view that relevant safety and efficacy data continue to support the approval of Makena, at least in a narrower indication.
  • Nevertheless, Covis respects the recommendations of the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, and, in light of its recommendations, is seeking to voluntarily withdraw the Makena NDA.
  • Shortly after the hearing, Covis outlined a plan for voluntary withdrawal that would have obviated the need for further proceedings.
  • As the company awaits a final decision by the FDA, Makena remains approved and the product label is unchanged at this time.

"GET THE F OUT OF THE FDA" Advertising Campaign Calls for New Food Agency: FDA food reorganization plan is a "dismal failure."

Retrieved on: 
Mercoledì, Marzo 8, 2023

Bill Marler says, " GET THE F OUT OF FDA, create a new dedicated Foods agency focused on food safety and nutrition."

Key Points: 
  • Bill Marler says, " GET THE F OUT OF FDA, create a new dedicated Foods agency focused on food safety and nutrition."
  • "And yet, the leadership of the FDA continues to be preoccupied with drug oversight and to give short shrift to food safety."
  • "People, including babies, have continued to die needlessly because the FDA has been slow to prevent foodborne illness.
  • I don't want to have to represent families who will have lost their children because FDA doesn't have the courage to act."

The CorVista® Analysis Provides a Robust Prediction for Elevated Left Ventricular End Diastolic Pressure at the Point-Of-Care

Retrieved on: 
Giovedì, Novembre 17, 2022

This publication follows the recent achievement of the Breakthrough Designation from the FDA for the CorVista System to aid in the diagnosis of pulmonary hypertension.

Key Points: 
  • This publication follows the recent achievement of the Breakthrough Designation from the FDA for the CorVista System to aid in the diagnosis of pulmonary hypertension.
  • The measurements are used for the prediction of LVEDP, a key indicator of heart failure.
  • These data suggest a potential role for the novel CorVista System to predict of an elevated LVEDP at the point-of-care.
  • In doing so, the CorVista System is uniquely poised to advance the quality of care in rural and low-resource settings.

CorVista Health Receives Breakthrough Device Designation for The CorVista® System

Retrieved on: 
Martedì, Ottobre 25, 2022

CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension.

Key Points: 
  • CorVista Health, Inc, a digital health company dedicated to improving cardiovascular disease diagnosis, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CorVista System as a first non-invasive point of care diagnostic solution for patients with suspected pulmonary hypertension.
  • While the CorVista System is not yet FDA cleared, we are hopeful that Breakthrough Device Designation will help expedite patient access to the CorVista System as a non-invasive point of care diagnostic solution.
  • CorVista Health is focused on FDAs recent call to action to better leverage health technologies to advance health equity as presented by FDA Commissioner, Dr. Robert Califf.
  • CorVista Health, Inc. is applying machine learning using real world test data to develop a novel cardiac diagnostic platform, CorVista System, with the aim of transforming cardiovascular care and the patient experience.

Highly Regarded Cell and Gene Therapy Expert, Dr. Michael Mendicino, Joins NDA Partners as Expert Consultant

Retrieved on: 
Martedì, Settembre 13, 2022

NDA Partners' General Manager, Eric Fish, announced today that Michael Mendicino, PhD, a highly regarded subject matter expert in cell and gene therapies and related platform technologies, has joined the company as an affiliated Expert Consultant.

Key Points: 
  • NDA Partners' General Manager, Eric Fish, announced today that Michael Mendicino, PhD, a highly regarded subject matter expert in cell and gene therapies and related platform technologies, has joined the company as an affiliated Expert Consultant.
  • WASHINGTON, Sept. 13, 2022 /PRNewswire-PRWeb/ -NDA Partners' General Manager, Eric Fish, announced today that Michael Mendicino, PhD , a highly regarded subject matter expert in cell and gene therapies and related platform technologies, has joined the company as an affiliated Expert Consultant.
  • Dr. Mendicino serves as a Chief Consultant and advisor for companies on CMC/CMC regulatory, regulatory strategy, development strategy, and diligence in the fields of cell and gene therapies, gene editing, regenerative medicine, tissue engineering, and xenotransplantation.
  • Dr. Mendicino is an accomplished leader in cell and gene therapies, and supports numerous professional organizations in the cell and gene therapies area.

National Alliance for Hispanic Health Calls Upon the FDA to Swiftly Finalize Proposed Rules to Prohibit Menthol Cigarettes and Flavored Cigars

Retrieved on: 
Lunedì, Agosto 1, 2022

WASHINGTON, Aug. 1, 2022 /PRNewswire/ -- "For decades, the tobacco industry has deliberately targeted youth and Hispanic communities with menthol and flavored products to lure in new generations of smokers. The FDA's recent moves to prohibit menthol in cigarettes and all flavors in cigars will save lives and advance health equity across this country and we urge FDA to finalize the rule swiftly and enact a 90-day implementation period," said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the Nation's leading Hispanic health advocacy group.

Key Points: 
  • The FDA's recent moves to prohibit menthol in cigarettes and all flavors in cigars will save lives and advance health equity across this country and we urge FDA to finalize the rule swiftly and enact a 90-day implementation period,"said Jane L. Delgado, PhD, MS, President and CEO of the National Alliance for Hispanic Health, the Nation's leading Hispanic health advocacy group.
  • "The Alliance applauds the FDA for acting on the clear science that evidences the harms of menthol in cigarettes and flavorings in cigars by issuing a pair of proposed rules for bans to protect the public health.
  • The time to act on menthol and flavored cigars is now, and there is strong public support for the bans, especially in Hispanic communities.
  • We urge the FDA to swiftly finalize the proposed rules and implement them within 90 days.