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The FDA released a draft guidance giving firms recommendations on provider-directed communication for off-label drug use.
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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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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).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FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications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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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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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 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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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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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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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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Industry group says FDA botched COVID-19 convalescent plasma guidance
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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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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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 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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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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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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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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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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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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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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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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FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
The FDA Law Blog
OCTOBER 10, 2023
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. For instance, FDA highlights risks associated with everyday activities (e.g.,
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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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.
Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?
The FDA Law Blog
NOVEMBER 2, 2023
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.
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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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Imodium interactions to avoid
The Checkup by Singlecare
NOVEMBER 11, 2023
Imodium carries a warning from the Food and Drug Administration ( FDA ) regarding an association between high doses and cases of sudden cardiac death. Communication is the second necessary precaution. Keep a list of prescription drugs , over-the-counter drugs, and supplements.
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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.
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Gabapentin interactions to avoid
The Checkup by Singlecare
NOVEMBER 30, 2023
Gabapentin is a generic medication approved by the Food and Drug Administration (FDA) to treat postherpetic neuralgia (nerve pain after shingles), epilepsy, other seizure disorders, and restless leg syndrome. Off-label use is when a drug is used for a purpose other than what it is approved for.
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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.
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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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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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.
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.
Does Blue Cross Blue Shield cover Ozempic?
The Checkup by Singlecare
APRIL 5, 2024
That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Dr. Foxman recommends that every patient review their formulary to see how Ozempic is covered and communicate directly with their insurer for clarity on the specific requirements. “It’s
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Cymbalta generic availability, cost, and dosage
The Checkup by Singlecare
OCTOBER 16, 2023
Food and Drug Administration (FDA) in 2004 , Cymbalta has become a widely used antidepressant to treat various mental health and pain-related conditions. What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Approved by the U.S.
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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.
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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Zolpidem interactions to avoid
The Checkup by Singlecare
DECEMBER 12, 2023
The Food and Drug Administration (FDA) even sent a special communication to call attention to this risk. Taking an active role in monitoring interactions and communicating concerns can minimize your risk. For that reason, it is typically best to avoid combining opiates with zolpidem.
Amlodipine interactions to avoid
The Checkup by Singlecare
JANUARY 23, 2024
Communicate these lists to every healthcare provider that cares for you. When to talk to a healthcare provider about amlodipine interactions Besides keeping and communicating lists, you should ask about interactions every time you are prescribed a new medication or are about to take an over-the-counter product.
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Citalopram interactions to avoid
The Checkup by Singlecare
JANUARY 30, 2024
Hailing from the selective serotonin-reuptake inhibitor ( SSRI ) class of drugs, citalopram is often used for the treatment of major depressive disorder or off-label use treating anxiety disorder. These communication efforts can make all the difference. For all the good work that it does, citalopram also has its downsides.
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Magnetic CPAP Masks: A Growing Concern for Patient Safety
Roots Analysis
DECEMBER 10, 2023
The strength of the magnetic fields raised the risk of interference from at least six inches away, prompting the FDA to assign a Class I rating, its most serious classification, to the recall. The FDA’s role in evaluating and addressing these safety concerns is pivotal, as demonstrated by its response to both ResMed and Philips recalls.
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Hydroxyzine interactions to avoid
The Checkup by Singlecare
OCTOBER 3, 2023
How to minimize hydroxyzine interactions Awareness and communication are your biggest allies in staying safe during medical treatment. Just because they are found in nature does not mean that herbs cannot harm you or interact with drugs like hydroxyzine. Your interest and inquisitions will be welcomed, and as a result, you will be safer.
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Eliquis interactions to avoid
The Checkup by Singlecare
JANUARY 18, 2024
Food and Drug Administration (FDA) to: Reduce the risk of stroke and blood clots in people who have irregular heart rhythms, a condition known as atrial fibrillation or Afib. To reduce the risk of forming a blood clot in the legs and lungs following hip replacement or knee replacement surgery.
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