Cytel

DECEMBER 8, 2023

Regular technical discussions with the FDA play a critical role in ensuring data submission success. Additionally, engaging in these discussions early on is particularly advantageous to improving the FDA’s confidence in your study. This approach enhances transparency and reduces the likelihood of later corrections.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Cytel

APRIL 26, 2023

Regular technical discussions with the FDA play a critical role in ensuring data submission success. Additionally, engaging in these discussions early on is particularly advantageous to improving the FDA’s confidence in your study. This approach enhances transparency and reduces the likelihood of later corrections.

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Alta Sciences

MARCH 4, 2025

This was in 2006, at a time when the FDA guidances on these topics had not yet been published. Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. corticosteroids, beta-blockers, antidepressants).

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Eye on FDA

AUGUST 16, 2023

In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This month FDA posted another letter , this one a Warning Letter involving a Sales Aid.

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The Pharma Data

DECEMBER 15, 2020

” Last week, the FDA approved a different at-home test, but it requires samples to be mailed to a lab to get the results. The new Ellume COVID-19 Home Test approved Tuesday detects SARS-CoV-2 virus protein fragments on nasal swab samples from any person 2 years of age or older, according to the FDA. © 2020 HealthDay.

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Agency IQ

JUNE 17, 2024

BY ALEXANDER GAFFNEY, MS, RAC Two lower courts had articulated a Rube Goldberg-esque theory of “standing” – the right of a person or organization to sue another entity – based on the idea that doctors not prescribing mifepristone or treating patients who had taken it had experienced economic harms.

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FDA Law Blog: Biosimilars

OCTOBER 10, 2023

(“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. Dr. Beitz was selected by FDA to be the inaugural Director of OII in March 2020 as part of the CDER OND reorganization.

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SCIENMAG: Medicine & Health

JUNE 9, 2023

Neither condition has diagnostic tests or treatments approved by the Food and Drug Administration (FDA) and each cost the United States billions of dollars each year in direct medical expenses and lost productivity. Doctors and researchers have wondered what are the underlying […]

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The Pharma Data

MARCH 30, 2021

Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. UBRELVY® Indication.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) has approved a label expansion of BOTOX ® to include eight new muscles for the treatment of upper limb spasticity in adults. BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. million adults in the U.S. About BOTOX ®.

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Drug Target Review

JANUARY 12, 2024

Today, diseases are only what we created as a way of naming disorders, a historic creation from doctors who studied patients that had common symptoms. Tempus health have a product, ‘Tempus One,’ that uses AI and databases they have developed along with data held in the medical centre to help doctors with treatment planning.

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The Pharma Data

SEPTEMBER 28, 2021

Many of our team at the FDA are parents and grandparents themselves, and our team shares an equivalent concerns as many in our country about protecting our loved ones from COVID-19. The FDA will work closely with each manufacturer to make sure this data analysis is strong and meets regulatory standards.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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Cytel

AUGUST 25, 2023

For several years, CDISC and Regulatory Data Submission expert Angelo Tinazzi has authored the series, The Good Data Submission Doctor , offering his insight and expertise on data submission and data integration. This collection details some of his most critical insights on clinical data standardization, including:

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PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). Topical and Redosable Gene Therapy On May 19, FDA approved Vyjuvek, a gene therapy for DEB. And so application of a gene therapy is the opposite of one-and-done; it must be much more frequent. Primary investigator M.

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The Pharma Data

MAY 19, 2023

ABBOTT RECEIVES FDA APPROVAL FOR TACTIFLEX™ ABLATION CATHETER FOR TREATMENT OF ABNORMAL HEART RHYTHM Abbott (NYSE: ABT) today announced that the U.S. 6 “Abbott is leading the way in helping doctors manage common arrhythmias with the most holistic portfolio for this condition in the world,” said Christopher Piorkowski, M.D.,

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The Pharma Data

JANUARY 20, 2021

Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet ® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021. Since its U.S. Esbriet U.S. Indication.

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Eye on FDA

JUNE 14, 2023

For those who are regular followers of what FDA’s Office of Prescription Drug Promotion (OPDP) is up to, there was a surprise this week when the office posted the first regulatory action letter – in this case an Untitled Letter (a/k/a Notice of Violation (NOV) Letter) in over a year.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. for use in appropriate pediatric patients.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% The FDA has set June 26, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date. (hereinafter, Santen), a global company focused exclusively on ophthalmology, today announced that the U.S.

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The Pharma Data

DECEMBER 4, 2021

” With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. Talk to your doctor if you are pregnant or plan to become pregnant. About Teva.

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Agency IQ

MAY 28, 2024

E&C lawmakers grill directors of FDA medical product centers Wednesday’s House E&C Health Subcommittee Hearing featured an extensive grilling of the leaders of FDA’s three medical products centers: CDER, CBER and CDRH. CBER Director Marks was first to respond on what FDA is doing to track its performance and resources. “I

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The Pharma Data

MAY 17, 2023

ABBOTT RECEIVES FDA APPROVAL FOR ITS SPINAL CORD STIMULATION SYSTEMS TO TREAT CHRONIC BACK PAIN IN PEOPLE WHO HAVE LIMITED SURGICAL OPTIONS Abbott (NYSE: ABT) announced today that the U.S. Additional key findings from the DISTINCT study included This new indication will span across the entirety of Abbott’s SCS portfolio in the U.S.,

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Controlled Substances Received from Multiple Providers Individuals presenting controlled substance prescriptions from multiple prescribers may indicate “doctor shopping.” Complaint ¶ 62. Providers should be aware of the other drugs prescribed to their patients. Complaint ¶ 63.

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Drug Target Review

SEPTEMBER 22, 2023

This recognition was codified by the United States Food and Drug Administration (FDA) in 2022 with the signing of the FDA Modernisation Act 2.0 Comprehensive analytical methods are then employed to evaluate the organoid’s cellular composition (e.g., 5 Organoids are recognised as New Alternative Methods (NAMs) in drug development.

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FDA Law Blog: Biosimilars

JUNE 22, 2023

Mullen — FDA has been clearing over-the-counter (OTC) in vitro diagnostic (IVD) tests nearly since the beginning of its premarket regulation of devices. The first OTC IVD cleared by FDA was a qualitative dipstick urine glucose test in 1977, followed shortly thereafter by the first OTC pregnancy test clearance in 1978. See Steven R.

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The Pharma Data

DECEMBER 17, 2020

Doctor Johnson has had an inspiring career that encompasses several aspects of the pharmacy industry. Doctor Johnson aspires to incorporate the latest technologies available in healthcare to care for her patients. Subsequently, she decided to pursue a higher education in pharmacology following her high school graduation.

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The Pharma Data

MARCH 26, 2021

It marks an important milestone in the vaccine roll-out, as it could allow storage in pharmacies to support vaccinations at local practices/doctors’ offices. By enabling more individuals to store and administer the vaccine, the approval will help broaden access, while limiting strain on larger vaccination centers.

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Drug Target Review

DECEMBER 4, 2023

According to the Personalised Medicine Coalition , 34 percent of all new drugs approved by the US Food and Drug Administration (FDA) in 2022 are personalised medicines. He holds a Doctorate in Biomedicine from Universitat Pompeu Fabra (ES) for the large-scale deployment of analyses and is the author of 14 peer-reviewed articles.

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KIF1A

APRIL 25, 2024

However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane. March 2024 – The FDA approved the IND, and the administering doctor (Dr.

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The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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The Pharma Data

JANUARY 15, 2021

Doctors are allowed to prescribe FDA-approved medications for unapproved uses when they believe it’s medically appropriate.). If Tyvaso is approved for ILD patients, Nathan foresees it as being another tool doctors can prescribe, along with oxygen therapy and pulmonary rehabilitation (which involves supervised exercise).

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The Pharma Data

SEPTEMBER 21, 2020

This follows a similar recall of thyroid medications that was issued by the FDA in recent weeks. Acella Pharmaceuticals is recalling two types of its thyroid medication as the drugs may be too weak to properly treat those who take them. .

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Eye on FDA

JULY 7, 2020

At mid-year, it has been a custom here at Eye on FDA to look back at a few categories of activity by FDA at the first half of the year and discern what it tells us about future directions. FDA said they would produce a guidance by the end of 2010, but did not. One of them was about the appropriate use of links.

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FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Walsh — As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs.

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The Pharma Data

SEPTEMBER 8, 2021

About BOTOX ® BOTOX ® was first approved by the FDA in 1989 for two rare eye muscle disorders – blepharospasm and strabismus in adults. Tell your doctor if you have any breathing-related problems. Tell your doctor if you have any breathing-related problems. Atogepant is currently under review by the U.S.

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