STAT

JANUARY 22, 2024

The reorganization was spurred by the FDA’s mishandling of the infant formula crisis. A nonprofit, nonpartisan advisory body reported in December it was not clear who is in charge of food oversight, and agency food safety staff are siloed among divisions that don’t communicate with each other.

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FDA Communication 117

STAT

AUGUST 20, 2024

And a group of researchers — including two from the FDA’s Center for Drug Evaluation and Research — think artificial intelligence could uncover more signs of these issues, including from electronic health records, social media posts, and clinical databases referencing certain drugs.

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FDA Communication Labelling Insurance 132

STAT

SEPTEMBER 11, 2024

29 letter that was posted on Wednesday on the FDA website. First, the TV spot suggests that the medication, which is called Ubrelvy, will “provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated,” according to an Aug.

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FDA Pharmaceutical Companies Pharmaceutical Companies Communication 123

Pharmaceutical Technology

OCTOBER 24, 2023

The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.

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Labelling FDA Communication 98

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

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The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications.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 105

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 331

STAT

AUGUST 14, 2024

Brain-computer interfaces are still years, and several FDA approvals, away from being available on the market.   One of the primary uses for BCIs is to provide better communication for people who have been paralyzed.   One of the primary uses for BCIs is to provide better communication for people who have been paralyzed.

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Communication FDA 121

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 104

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

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 98

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

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

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

Pharma Marketing Network

DECEMBER 4, 2024

Companies are investing heavily in digital tools to streamline communication and build stronger connections. Strategies like storytelling, personalized educational content, and two-way communication channels create trust and build loyalty. Patient-Centric Marketing Patients want to feel heard.

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Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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 Communication Insurance 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

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

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

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

PharmExec

AUGUST 16, 2023

In its second warning letter issued in 2023, the FDA has sternly cautioned AstraZeneca for misleading claims in the promotional materials of its Breztri Aerosphere inhalation aerosol; this marks the first warning letter AstraZeneca has received this year.

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Communication FDA 52

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA Documentation Communication 105

Pharma Marketing Network

MARCH 11, 2025

Platforms like Salesforce Health Cloud and Veeva Systems help teams organize data, automate communication, and improve relationship management. Platforms like Mailchimp and HubSpot provide automation features, ensuring personalized and compliant communication. Marketers must balance engagement with strict industry guidelines.

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HIPAA Communication FDA Insurance 52

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

STAT

NOVEMBER 16, 2022

The exit of Soumya Swaminathan, an Indian pediatrician, comes as the second term of WHO Director-General Tedros Adhanom Ghebreyesus as leader of the 74-year-old global health agency gets underway. Swaminathan did not offer a reason.

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Communication FDA 98

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

BioPharm

JULY 1, 2024

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

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FDA Communication 52

Pharma Marketing Network

MARCH 8, 2025

It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. Compelling and Compliant Headline Clearly communicate value (e.g., Avoid misleading claims Always align with FDA-approved language. What makes a pharma landing page effective?

HIPAA 59

HIPAA FDA Communication 59

STAT

OCTOBER 17, 2024

Spoiler alert: The clear takeaway from the meeting is that the hub will succeed only if everyone involved prioritizes better internal and external communications. But how can it become more than just another case of an aspirational agency press release’s best intentions failing to make a difference?

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Communication FDA 104

Pharmaceutical Technology

JANUARY 24, 2023

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. Neurogene stated that the FDA IND clearance allows it to commence a Phase II/II trial of NGN-401 in female paediatric Rett syndrome patients.

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FDA Communication Labelling 83

Pharma Marketing Network

MARCH 27, 2025

The shift is largely due to changes in user behavior, regulatory clarity, and the demand for more personalized, real-time communication. Brands tiptoed around platforms like Facebook or Twitter, fearful of FDA repercussions, adverse event reporting, and lack of clear guidance. Social is no longer one-way communication.

HIPAA 52

HIPAA Communication FDA Labelling 52

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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Documentation FDA Communication 59

The FDA Law Blog

AUGUST 23, 2022

By doing so, FDA has limited the number of tests that have reached the market, thereby reducing available supply and increasing prices. As FDA would acknowledge, the antigen tests are the fastest and most practical method for distributing testing in the general population. That could happen again.

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Labelling Communication FDA Medical Schools 97

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

pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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FDA Communication Insurance Patient Care 95

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

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