BioPharm

OCTOBER 5, 2023

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

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FDA Communication 98

The FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Labelling FDA Communication 64

European Pharmaceutical Review

OCTOBER 17, 2023

The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.

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FDA Communication Packaging 85

The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g., l)(1) (e.g.,

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Labelling Communication FDA 59

The Checkup by Singlecare

MARCH 8, 2024

Food and Drug Administration (FDA) approved the first over-the-counter (OTC) continuous glucose monitor (CGM). Especially for people who are managing diabetes, the Stelo GCM should be used in communication with a healthcare team. The post FDA approves the first OTC continuous glucose monitor appeared first on The Checkup.

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FDA Insurance Communication 98

pharmaphorum

JANUARY 20, 2022

There are umbrellas like FDA, IFPMA, et cetera. Then you’ve got the FDA in the US, ADPI in the UK, ANSM in France. The post Content metrics help generate compelling communication appeared first on. The information companies provide in their content has to be accurate. Every country has its regulations. Each of those nuances.

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Communication FDA Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

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FDA Communication Dosage 105

PharmExec

SEPTEMBER 29, 2023

The program will offer participants more opportunity to communicate with FDA staff.

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FDA Communication 52

The FDA Law Blog

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market. By John W.M.

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FDA Communication 59

Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA will consider the AdCom as it reviews the drug’s sNDA.

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FDA Medical Schools Labelling Communication 96

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

European Pharmaceutical Review

MAY 11, 2023

The US Food and Drug Administration (FDA) has released a discussion paper to complement and inform future guidance on artificial intelligence (AI) and machine learning (ML) in drug development. The paper is intended to initiate communication with stakeholders, including industry and academia, to foster mutual learning and discussion.

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FDA Communication 77

The FDA Law Blog

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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FDA Communication 59

European Pharmaceutical Review

SEPTEMBER 22, 2022

Due to the progressive, and eventually fatal nature of the diseases, finding a cure quickly is of upmost importance to the pharmaceutical community. The collaborators will utilise the Critical Path Institute (C-Path) to help manage their communications. Patient-focused drug development will be a key effort for the CP-RND.

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FDA Communication 74

pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. “Despite….advantageous “Despite….advantageous

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FDA Labelling Communication 98

Pharmafile

MARCH 2, 2023

Yesterday, GSK shared that an advisory committee from the FDA voted in support of its respiratory syncytial virus (RSV) vaccine candidate for older adults. This support is ahead of an official FDA approval for the company’s vaccine. GSK has shared that a final decision is expected to be made by the FDA ahead of the 3 May.

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Vaccines FDA Communication 98

STAT

MARCH 11, 2023

The Food and Drug Administration on Friday approved the first treatment for Rett syndrome, a genetic disease mostly affecting girls that causes severe neurologic impairments, robbing them of the ability to communicate or control muscle movement. The new drug, called Daybue, is made by Acadia Pharmaceuticals.

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Communication FDA 98

pharmaphorum

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. We will communicate our final conclusions and recommendations when we have completed our review or have more information to share.”.

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FDA Communication Labelling Patient Care 78

The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ). This statistic is quite disheartening.

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FDA Documentation Labelling Communication 59

European Pharmaceutical Review

MAY 9, 2024

This order directed the three agencies to improve their implementation of The Coordinated Framework for the Regulation of Biotechnology, FDA stated. FDA highlighted that the collaborators’ plan also meets another of the President’s goals: ensuring that the public is confident in the biotechnology regulatory system.

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FDA Communication 64

The FDA Law Blog

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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FDA Communication 64

Pharmafile

MARCH 17, 2023

The FDA has approved Novartis’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of BRAF V600E low-grade glioma (LGG) in paediatric patients over the age of one. Liquid formulations of the drugs have also been approved to make administration easier across various approved indications. read more

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FDA Communication 96

IDStewardship

APRIL 14, 2024

These advancements are evidenced by the two FDA-approved FMT products available for rCDI prevention: Rebyota (Fecal Microbiota, Live-jslm) and Vowst (Fecal Microbiota Spores, Live-brpk). Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved. Am J Gastroenterol. Jain N, Umar TP, Fahner AF, Gibietis V.

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FDA Hospitals Communication 324

pharmaphorum

JUNE 3, 2021

The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. ” The post FDA grants swift approval to Cognoa’s digital device for autism diagnosis appeared first on.

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FDA Communication 114

Pharmaceutical Technology

JUNE 9, 2023

Rocket Pharmaceuticals has received fast track and orphan drug designations for RP-A601 from the US Food and Drug Administration (FDA) to treat plakophilin-2-related arrhythmogenic cardiomyopathy (PKP2-ACM). In April 2023, the FDA approved the investigational new drug (IND) application for RP-A601 to begin a Phase I clinical trial.

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FDA Communication 59

pharmaphorum

AUGUST 27, 2020

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. The post Industry group says FDA botched COVID-19 convalescent plasma guidance appeared first on.

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FDA Mayo Clinic Labelling Communication 106

Pharmafile

MARCH 10, 2023

A committee at the FDA have voted in favour of Roche’s Polivy antibody drug targeting untreated diffuse large B cell lymphoma, which is the most common form of non-Hodgkin lymphoma in the US. This committee only supplies the FDA with independent opinions and recommendations, however an official FDA decision is expected by 2 April 2023.

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FDA Communication 64

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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FDA Documentation Communication 45

PharmExec

JULY 7, 2023

Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.

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Labelling Communication FDA 52

Pharmafile

JANUARY 27, 2023

The FDA is calling on the US Congress to work with them on a new regulatory pathway for cannabidiol (CBD). According to the FDA, there have been some safety concerns around CBD, especially with its long-term use. CBD is the non-psychoactive ingredient from the cannabis plant generally considered to have wellness properties.

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FDA Communication 88

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. But we digress.

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Labelling FDA Vaccines Communication 40

pharmaphorum

JULY 20, 2021

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The post FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy appeared first on.

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FDA Communication Immunization 98

Pharmafile

JANUARY 11, 2023

The FDA has cleared the ACL TightRope® II implant to treat torn knee ligaments in children and adolescents. The implant was developed with the aim of addressing a so-called ‘epidemic’ of knee injuries in young athletes who are at higher risk of anterior cruciate ligament (ACL) injuries. read more.

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FDA Communication 95

PharmExec

JANUARY 11, 2023

The parameters governing pharma promotional speech in digital and social media have struggled to keep pace with the rapidly evolving healthcare communications landscape. How can FDA play catch-up in advancing an agenda more reflective of industry and patient needs?

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Communication FDA 72

Pharmafile

MARCH 27, 2023

The FDA has released a draft of new guidance for accelerated approval for oncology therapeutics, highlighting the need for stricter clinical trial design. read more

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FDA Communication 72

Pharmafile

APRIL 26, 2023

The US Food and Drug Administration (FDA) has released a Public Safety Notification on eyedrops containing amniotic fluid currently being sold to treat, mitigate or cure diseases or conditions including dry eye disease. read more

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FDA Communication 72

Pharmafile

MARCH 24, 2023

NeuroRPM has announced that it has received clearance from the FDA for its NeuroRPM device which uses AI and existing Apple Watch technology to monitor symptoms of Parkinson’s disease, offering continuous, day-to-day tracking of symptoms. read more

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FDA Communication 90