The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

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FDA Documentation 59

Pharmacy Times

MAY 16, 2023

Since the 2018 guideline’s publication, additional non-statin therapies such as bempedoic acid, evinacumab, and inclisiran, have been approved by the FDA for the management of hypercholesterolemia.

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FDA 119

STAT

JANUARY 3, 2024

FDA nods for innovative therapies containing an active ingredient or molecule not previously approved, rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. Historical data show the FDA typically greenlights about 45 to 50 new drugs a year, and approvals hit a peak of 59 in 2018.

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The Checkup by Singlecare

NOVEMBER 18, 2022

Food and Drug Administration (FDA). The FDA recently okayed the extension for the duration of use of the popular hormonal IUD in the prevention of pregnancy from six years to eight years. . There are several benefits to this recent FDA approval. The post FDA grants approval for 8-year Liletta appeared first on The Checkup.

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The FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

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FDA Research Laboratories Documentation 69

pharmaphorum

SEPTEMBER 13, 2022

The FDA has started a priority review of Chiesi ‘s velmanase alfa, an enzyme replacement therapy for lysosomal storage disease (LSD) alpha-mannosidosis, with a decision expected in the first half of 2023. The post FDA starts review of first drug for alpha-mannosidosis, from Chiesi appeared first on.

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FDA 104

European Pharmaceutical Review

FEBRUARY 17, 2023

The US Food and Drug Administration (FDA) has approved Lamzede ® (velmanase alfa-tycv) for non-central nervous system manifestations of alpha-mannosidosis (AM) in adult and paediatric patients. The post Enzyme replacement therapy for alpha-mannosidosis gets FDA approval appeared first on European Pharmaceutical Review.

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FDA 88

Pharmaceutical Technology

JUNE 21, 2023

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. Recently, the FDA granted approval for Milla Pharmaceutical’s generic version of the drug to help with shortages in the US. Dexmedetomidine is commercially available as Precedex, marketed by Pfizer.

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FDA 80

STAT

NOVEMBER 30, 2023

Even before the Covid pandemic, a 2018 paper reported that new genetic tests, many of them for increasingly rare conditions, were being released at the rate of 10 a day. You can now avail yourself of noninvasive diagnostics that claim to screen for rare birth defects, cancer-associated mutations, and even Alzheimer’s.

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Labelling FDA 106

Pharmaceutical Technology

JUNE 1, 2023

The US Food and Drug Administration (FDA) has granted a combination of AstraZeneca and MSD ’s Lynparza (olaparib), with standard therapies for treating BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Trials peaked at 115 in 2018 before declining to 91 last year.

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FDA Chemotherapy 97

pharmaphorum

FEBRUARY 5, 2021

The change of administration in the US has also seen a new leader at the FDA, with Dr Janet Woodcock appointed as interim commissioner by president Joe Biden’s new team. Dr Janet Woodcock would at first seem like a safe pair of hands as the new chief of the FDA, an insider who has been part of the organisation since the eighties.

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FDA Vaccines Labelling 117

The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. The purpose of this program is to reduce the volume of reports that a manufacturer needs to submit to FDA and to “make malfunction event trends more readily apparent.”. By McKenzie E.

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FDA Documentation 59

pharmaphorum

AUGUST 4, 2021

The HDAC inhibitor was given an accelerated approval by the FDA as a second-line PTCL therapy on the strength of overall response data, but a phase 3 study comparing Istodax to first-line chemotherapy showed no improvement on progression-free survival (PFS).

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FDA Chemotherapy Labelling 98

The FDA Law Blog

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes. By John W.M. Claud & Sara W. What are nitrosamines?

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The FDA Law Blog

MARCH 6, 2023

The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. In the proposed rule, FDA stated that any final rule would become effective one year after the date of publication of the final rule in the Federal Register.

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FDA 105

The FDA Law Blog

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Note that FDA is currently soliciting applications to staff this committee. Tobolowsky & James E. Raver & Frank J.

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FDA 59

pharmaphorum

APRIL 27, 2021

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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FDA Chemotherapy Documentation 74

STAT

OCTOBER 4, 2023

Samples collected between 2018 and 2022 led researchers to platelet collection products made by the company at a plant in Puerto Rico. Food and Drug Administration cited the company for contamination problems and other quality control issues at the same facility.

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FDA 94

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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FDA Documentation Packaging Communication 75

pharmaphorum

FEBRUARY 23, 2021

Sanofi’s cancer immunotherapy Libtayo (cemiplimab) has a third US indication after the FDA approved it for certain untreated lung cancer patients. Libtayo was first FDA-approved in late 2018 for advanced cutaneous squamous cell carcinoma, followed by advanced basal cell carcinoma last month.

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FDA Chemotherapy 103

The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

PharmaShots

APRIL 6, 2023

A recent study published in the January 2023 issue of Clinical Pharmacology and Therapeutics described essential characteristics of a PD biomarker for biosimilar development.

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FDA 53

Pharmaceutical Technology

APRIL 3, 2023

HUTCHMED (China) has completed the new drug application (NDA) rolling submission to the US Food and Drug Administration (FDA) for fruquintinib to treat refractory metastatic colorectal cancer (CRC). Fruquintinib is an important treatment option for patients with metastatic CRC in China, where it has been available to patients since 2018. “We

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pharmaphorum

NOVEMBER 18, 2021

A virtual reality system developed by AppliedVR that has been shown in trials to help reduce chronic lower back pain has been approved by the FDA as a prescription digital therapeutic (DTx). The post AppliedVR’s virtual reality therapy for pain cleared by FDA appeared first on. billion in lost productivity in a year.

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FDA Chemotherapy 93

Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.

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FDA Immunization 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. Established in 2018, AceLink focuses on the development of therapies for genetic ailments with unmet needs.

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FDA 52

Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

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FDA 52

pharmaphorum

MAY 24, 2022

Shares in US biotech Nymox Pharma have plunged after the company announced the FDA had refused to accept its marketing application for its drug candidate for benign prostatic hyperplasia (BPH), a common condition affecting older men. The post Nymox slumps as FDA rejects filing for prostate drug appeared first on.

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FDA Communication 57

STAT

FEBRUARY 13, 2024

In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage. Ultimately, this medicine was shown to have a better side effect profile than TDF.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The post Can the FDA keep the momentum going for rare disease drug approvals?

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FDA Communication Dosage 126

pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). Additionally, under its 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application (NDA) through to FDA approval.

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FDA 52

Pharmacy Times

SEPTEMBER 7, 2022

The FDA initially approved baloxavir marboxil in October 2018 for the treatment of acute, uncomplicated influenza.

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FDA 65

pharmaphorum

NOVEMBER 9, 2022

AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.

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FDA Labelling 57

The FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

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FDA Documentation 115

pharmaphorum

AUGUST 12, 2020

The FDA has started its review of Israeli biotech Protalix BioTherapeutics and partner Chiesi’s Fabry disease therapy pegunigalsidase alfa, setting up a possible approval by 27 January. The initial application with the FDA is for dosing of 1mg/kg pegunigalsidase alfa every two weeks, the same interval as Fabrazyme and Replagal.

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FDA 96

pharmaphorum

DECEMBER 18, 2020

GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. AstraZeneca wasn’t so fortunate with its anifrolumab candidate, which flunked a pivotal trial in SLE in 2018, but still thinks it has potential.

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