FDA cracks down on off-label drug use messaging
Pharmaceutical Technology
OCTOBER 24, 2023
The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.
Communication FDA Labelling 
STAT+: Q&A: How the FDA could use AI for drug and device safety surveillance
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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RFID: The future of smart labelling?
Pharmaceutical Technology
MARCH 22, 2023
The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format. In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023.
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Skinny Label and Induced Infringement: The Saga Continues
The FDA Law Blog
MAY 11, 2023
government in the now-infamous (at least in FDA circles) Teva v. GSK skinny label case , the U.S. The Government’s concern goes far beyond this case: Like many generic drug sponsors, the Government raises concerns of the implications of the outcome of this case on the skinny label pathway itself.
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Hard times at Ardelyx as FDA rejects kidney disease drug tenapanor
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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From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information
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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).
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FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD
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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COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again
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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12 Medications With Off-Label Uses
BuzzRx
JANUARY 27, 2023
Food and Drug Administration (FDA) has to undergo several rigorous phases before approving new medications. Once the FDA approves a new drug, it means that when using this drug for an approved condition, the potential benefits outweigh the potential risks. The term “on-label use” of a drug may seem unfamiliar to most people.
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FDA holds back from action over Xeljanz safety study
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’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications
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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FDA-Approved Labeling: Is Enough Enough?
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.
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How Has Social Media Advertising Changed in Pharma
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.
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FDA Stresses Consumer-Friendly Promotional Labeling, Ads
PharmExec
JULY 7, 2023
Newly-issued final guidance focuses on language used when communicating quantitative efficacy or risk information.
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US FDA clears Transcenta’s IND for Rett syndrome treatment
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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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
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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Are Predetermined Change Control Plans on the road to Global Harmonization?
The FDA Law Blog
NOVEMBER 29, 2023
Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. FDA considers these guiding principles as complimentary to their recent efforts around PCCPs including their proposed draft guidance on PCCPs.
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It’s the Law Now –Cybersecurity Information in Premarket Submissions
The FDA Law Blog
APRIL 25, 2023
The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. It applies whether the software is the entire device (i.e.,
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Sharing oncology trial PROs to build the treatment of the future
pharmaphorum
AUGUST 24, 2020
In the United States, the 21st Century Cures Act encouraged the Food and Drug Administration (FDA) to review and communicate patient experience data from trials – but the lack of a common framework for submissions and space on product labels has, until now, been something of a stumbling block. .
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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions
Pharmaceutical Technology
JULY 20, 2022
On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.
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Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
The FDA Law Blog
JULY 7, 2024
Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.
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Helping FDA Help Itself: Voluntary Submissions of Allegations of Regulatory Misconduct
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 ). Supporting information is critical to illustrate the specific points of regulatory misconduct.
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FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule
The FDA Law Blog
SEPTEMBER 22, 2024
The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).
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Compounded semaglutide side effects
The Checkup by Singlecare
FEBRUARY 17, 2025
Its not safe or effective, according to the Food and Drug Administration (FDA), and it may lead to serious health problems. Although these medications are effective, the FDA has not yet approved generic versions, meaning people can only get a prescription for semaglutide under its brand name. Is compounded semaglutide safe?
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Considerations for Mobile Health Technology Developers: Part 2
pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.
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Aduhelm approval controversy dials up as FDA seeks probe
pharmaphorum
JULY 11, 2021
In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”
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It’s a Cruel Summer – Two New OPDP Untitled Letters
The FDA Law Blog
AUGUST 11, 2024
The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The website also included claims from “data on file” that were based on “pooled DOR” information.
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Can a nasal spray tackle agitation in autism?
Pharmaceutical Technology
JULY 29, 2022
Dr Jeremy Veenstra-VanderWeele, professor of developmental neuropsychiatry at the Columbia University Irving Medical Center, explains that agitation is seen in the minority of autistic teens, who struggle with communication. An inability to clearly communicate with others and express their wants and needs results in frustration, he adds.
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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act
The FDA Law Blog
OCTOBER 10, 2022
Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. FDA interprets the term “pattern” to mean “multiple, sequential, or repeated measurements of a signal or from a signal acquisition system.”
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Fennec’s hearing loss drug for cancer patients wins breakthrough FDA nod
Pharmaceutical Technology
SEPTEMBER 23, 2022
The recent FDA approval of Fennec Pharmaceuticals’ drug PEDMARK (sodium thiosulfate injection) marks a significant advance for cancer treatment-associated hearing loss therapies, amidst a bid to improve quality of life for cancer patients. In 2018, the FDA had granted Pedmark a breakthrough orphan drug designation.
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Digital therapeutics and healthcare innovation
pharmaphorum
OCTOBER 12, 2018
The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label.
Navigating Regulatory Challenges in Pharma Marketing: Best Practices
Pharma Marketing Network
AUGUST 9, 2023
Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.
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What is the best medication for anxiety and insomnia?
The Checkup by Singlecare
FEBRUARY 6, 2023
These drugs have a black box warning , which is the strongest warning required by the US Food and Drug Administration (FDA). It is FDA-approved to treat depression (also known as major depressive disorder), but sometimes healthcare providers prescribe this medication off-label for other uses.
How to stop taking Ozempic safely
The Checkup by Singlecare
OCTOBER 22, 2024
You’ve probably heard the buzz about Ozempic (active ingredient semaglutide), a popular brand name, FDA-approved Type 2 diabetes medication that’s also used off-label for weight loss. By maintaining open communication with your healthcare provider and making necessary lifestyle adjustments, you can stop taking Ozempic safely.
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Axsome faces delay for depression drug, hitting shares hard
pharmaphorum
AUGUST 11, 2021
The FDA was supposed to be delivering its verdict on Axsome Therapeutics’ depression therapy AXS-05 in less than a fortnight – but instead has delivered the company a letter outlining deficiencies in its marketing application.
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OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
The FDA Law Blog
AUGUST 16, 2023
The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Therefore, the presentation of these claims (i.e., What does this mean
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Email Marketing Campaigns for Pharma: Boost Engagement & Compliance
Pharma Marketing Network
FEBRUARY 19, 2025
Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging.
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What to avoid when taking gabapentin
The Checkup by Singlecare
JUNE 23, 2023
Food and Drug Administration (FDA) to treat postherpetic neuralgia from shingles , partial seizures due to epilepsy , and moderate to severe restless legs syndrome (RLS). It’s essential to read the label before you pop that pill (or oral solution) and take it as advised. Gabapentin is approved by the U.S.
Navigating Regulatory Challenges in Pharma Marketing: Best Practices
Pharma Marketing Network
AUGUST 9, 2023
Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.
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Alprazolam interactions to avoid
The Checkup by Singlecare
MARCH 8, 2024
Food and Drug Administration (FDA) to manage generalized anxiety disorder. It is also used off-label for other forms of anxiety, like agoraphobia, panic disorders, and acute vertigo episodes. Other benzodiazepines include clonazepam, diazepam, and lorazepam.
How Often Can I Take Codeine Cough Syrup?
BuzzRx
DECEMBER 8, 2022
Read the product label and follow the prescription’s instructions carefully. What is the FDA drug safety communication regarding codeine cough medicine? Food and Drug Administration (FDA) restricts the use of prescription codeine pain medicines and tramadol in children. You should not exceed 20 mL (2 doses) in 24 hours.
Complete guide on pharmaceutical medical affairs
Viseven
NOVEMBER 17, 2022
Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.
Global impact: How regulatory affairs is shaping development of cutting-edge pharma innovation
pharmaphorum
APRIL 15, 2021
As these innovations – which have the potential to be transformative for patients – enter uncharted regulatory territory, the pathway is not always clear or well-defined, which is why Astellas adopts a proactive approach to early communication with health authorities. “We Looking to the future.
Adderall side effects in females
The Checkup by Singlecare
MARCH 7, 2024
Additionally, Adderall isn’t approved by the Food and Drug Administration (FDA) for weight loss. The Adderall drug label shows no reports of adverse effects in a breastfeeding infant, but long-term effects are unknown. Children : Adderall is FDA approved for use by children with ADHD ages 3–17.
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