The Pharma Data

DECEMBER 18, 2020

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S.

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The Pharma Data

NOVEMBER 29, 2021

Food and Drug Administration today approved Cytalux (pafolacianine), an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery. Related Information.

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The Pharma Data

NOVEMBER 23, 2021

director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Approval is for Cytomegalovirus, a Type of Herpes Virus. Today, the U.S.

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The Pharma Data

FEBRUARY 19, 2022

Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. The agency is also advising that all drugs, medical devices, cosmetics and dietary supplements, regardless of packaging, be discarded. Today, the U.S. 1, 2021, through the present.

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The Pharma Data

NOVEMBER 21, 2021

Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates), meaning these children still have the potential to grow. director of the Division of General Endocrinology in the FDA’s Center for Drug Evaluation and Research.

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FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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The Pharma Data

MAY 17, 2021

Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.

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Pfizer

AUGUST 15, 2022

I am grateful to have received four doses of the Pfizer-BioNTech vaccine and I am feeling well while experiencing very mild symptoms. I am incredibly grateful for the tireless efforts of my Pfizer colleagues who worked to make vaccines and treatments available for me and people around the world. NEW YORK, AUGUST 15, 2022 – Pfizer Inc.

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The Pharma Data

MARCH 29, 2022

Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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The Pharma Data

APRIL 7, 2023

Food and Drug Administration announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Today, the U.S.

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FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

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The Pharma Data

FEBRUARY 24, 2022

Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. Today, the U.S. Related Information. The FDA, an agency within the U.S.

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The Pharma Data

DECEMBER 4, 2020

Food and Drug Administration (FDA) authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B (flu). Food and Drug Administration. . SILVER SPRING, Md. , 4, 2020 /PRNewswire/ — Today, the U.S. .

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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Roots Analysis

FEBRUARY 20, 2022

Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. As a matter of fact, recently many drug developers have initiated formulating novel therapeutic interventions that utilize nanoparticles as a major component ( nanomedicines ). Our Social Media Platform.

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The Pharma Data

APRIL 20, 2022

Food and Drug Administration is warning the public of the risk of false results, inappropriate use and inappropriate interpretation of results with non-invasive prenatal screening (NIPS) tests, also called cell-free DNA tests or non-invasive prenatal tests (NIPT). Today, the U.S.

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XTalks

NOVEMBER 28, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). Safrole is also a precursor in the synthesis of some psychoactive drugs.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration took new steps aimed at fostering the development of non-addictive alternatives to opioids to manage acute pain and decreasing exposure to opioids and preventing new addiction. director of the FDA’s Center for Drug Evaluation and Research. Today, the U.S.

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The Pharma Data

DECEMBER 30, 2020

Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Food and Drug Administration. View original content to download multimedia: [link]. SOURCE U.S.

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The Pharma Data

APRIL 15, 2022

Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. Today, the U.S.

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The Pharma Data

APRIL 28, 2022

Food and Drug Administration is announcing proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. Today, the U.S. by reducing youth experimentation and addiction, and increasing the number of smokers that quit.

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Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. CADTH makes non-binding recommendations on public drug reimbursement (except in Quebec). PMPRB in flux.

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The Pharma Data

SEPTEMBER 28, 2021

Food and Drug Administration will meet with members of the food industry, regulatory counterparts in the least levels of state , consumers, et al. However, during the pandemic the amount of usa citizens ordering food for delivery has skyrocketed, consistent with reports of consumer spending. Additional Information On Oct. 19-21, the U.S.

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The Pharma Data

JUNE 2, 2022

Food and Drug Administration launched a new initiative, Supplement Your Knowledge , to help educate, inform, and broaden consumer, educator and healthcare professional understanding of dietary supplements. Today, the U.S. More than half of all Americans take dietary supplements daily or on occasion.

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The Pharma Data

FEBRUARY 13, 2022

Food and Drug Administration’s top priorities is to improve the health of Americans through better nutrition. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

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The Pharma Data

MARCH 7, 2022

Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination). Today, the U.S.

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The Pharma Data

NOVEMBER 12, 2021

Food and Drug Administration is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. Today, the U.S. director of the FDA’s Center for Devices and Radiological Health.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula on U.S. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The Pharma Data

FEBRUARY 18, 2022

Food and Drug Administration announced it is investigating consumer complaints of Cronobacter sakazakii and Salmonella Newport infections. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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pharmaphorum

DECEMBER 15, 2022

We’re seeing everything from over-the-counter cold medication to cosmetic injection brands leverage different tiers of influencers. Back in 2015, the influencer-of-influencers, Kim Kardashian, was slammed for failing to mention the potential side effects of an anti-nausea drug, leading to the US FDA getting involved.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S.

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The Pharma Data

MAY 16, 2022

Food and Drug Administration is announcing a guidance that outlines increased flexibilities regarding importation of certain infant formula products to further increase the availability of infant formula across the country while protecting the health of infants. Today, the U.S.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. Food and Drug Administration. SILVER SPRING, Md. , 14, 2020 /PRNewswire/ — Today, the U.S. .

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Pfizer

DECEMBER 20, 2022

FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

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Roots Analysis

AUGUST 8, 2023

Furthermore, a wide variety of drugs and macromolecules, including DNA , proteins, and imaging agents, can be encapsulated in liposomal vesicles due to their unique ability to entrap both lipophilic and hydrophilic substances. The various therapeutic applications of liposomes in drug delivery have been highlighted in the figure.

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The Pharma Data

NOVEMBER 6, 2020

Food and Drug Administration (FDA) permitted marketing of a new device intended for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from post-traumatic stress disorder (PTSD). Food and Drug Administration. .

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