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The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days.
It must convert visitors into leads , provide clear and accurate medical information , and ensure compliance with FDA, HIPAA, and ad platform policies. For expert pharma marketing insights, visit Pharma Marketing Network. Avoid misleading claims Always align with FDA-approved language. Heres how to ensure yours is effective.
The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.
Unlike traditional businesses, pharma brands face strict advertising regulations , requiring compliance with FDA guidelines, HIPAA, and Googles healthcare ad policies. Strict ad copy guidelines , including FDA-mandated fair balance requirements. For expert insights on pharma digital advertising , visit Pharma Marketing Network.
Brands tiptoed around platforms like Facebook or Twitter, fearful of FDA repercussions, adverse event reporting, and lack of clear guidance. However, the FDA and other regulators have clarified their positions in recent years, particularly around fair balance and risk disclosures. Still, human oversight is critical.
In addition, pooled analysis results from the combined primary efficacy endpoint and safety data from RADIANCE SOLO, RADIANCE TRIO, and RADIANCE II were concurrently published in JAMA Cardiology. The study also achieved its primary safety composite outcome with no major adverse events observed. mmHg, compared to a reduction of -1.8
Oracle company Cerner Enviza and John Snow Labs have collaborated with the US Food and Drug Administration (FDA) for the development of artificial intelligence (AI) tools for drug safety and real-world evidence studies.
New FDA guidelines, competitor brand moves, and media spending trends all influence how your brand should show up in-market. The Pharma Marketing Network offers deep dives into trends, case studies, and tactical marketing guidance tailored for pharma marketers. Start by bookmarking reliable, industry-recognized sources.
LinkedIn Ads: The Professional HCP Network LinkedIn is an ideal platform for B2B pharma marketing, offering precise targeting based on job title, specialty, and industry. Best For: Thought leadership, industry networking, and professional event promotions. Avoiding misleading claims that exaggerate efficacy or safety.
Patient Education Instagram, Facebook, and TikTok help spread disease awareness and medication safety information. The Digital Shift in Healthcare 70% of HCPs use social media for professional purposes , including medical education and networking. For expert pharma marketing insights, visit Pharma Marketing Network.
So how can pharma brands maximize their return on investment (ROI) while ensuring compliance with FDA and HIPAA regulations ? A single misstepsuch as targeting the wrong audience or omitting safety disclaimers can lead to regulatory violations and ad disapprovals. For more pharma marketing insights, visit Pharma Marketing Network.
a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.
Food and Drug Administration (FDA) 510(k) clearance for its CellFX System, expanding the indication for use to include the treatment of sebaceous hyperplasia in patients with Fitzpatrick skin types I-III. See Full Press Release at the Source: Pulse Biosciences Announces FDA 510(k) Clearance for the Treatment of Sebaceous Hyperplasia.
Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study, a multi-center, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure PerQseal ® Closure Device System. The post Vivasure Medical Announces FDA IDE Approval to Initiate U.S.
implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Press Release by: Hip Innovation Technology. Are you hiring?
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WISE Srl, a medical device company developing next-generation implantable electrodes for neuromonitoring, neuromodulation and brain-machine interfacing (BMI), announced the FDA clearance of its WISE Cortical Strip (WCS®) , a single use medical device intended to be used on the brain surface for Intra Operative Neurophysiological Monitoring (IONM).
The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.
FDA clearance for expanded indications for use for the Hummingbird® Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. The company’s goal is to broaden the options available to ENTs and parents, focusing on the safety and comfort of the child, while reducing healthcare costs. Preceptis Medical, Inc.,
Veeva’s industry experts share their predictions about how breaking down silos across clinical, regulatory, safety, and quality teams will benefit patients. Safety will create a single source of truth for content management. Data will unlock clinical and economic value in Europe’s challenging landscape.
Example: If promoting Jardiance for diabetes management, focus on unique selling points like proven efficacy and FDA approval. Ensure your ads comply with FDA guidelines. Example: When advertising a drug like Lyrica , your ad must state potential side effects and direct users to detailed safety information.
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Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The X1 also has a state-of-the-art anatomic modality previously cleared by the FDA for solid tumors located anywhere in the body.
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In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.
Follow FDA guidelines on advertising to ensure your messaging is accurate and ethical. Highlight topics like disease awareness, drug safety, and lifestyle tips to add value to your audience. Follow FDA guidelines, ensure accurate messaging, and work closely with legal and regulatory teams to review campaigns.
With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.
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The alliance will focus on measures to expedite the clinical programme of NKGen using its autologous NK cell therapy, SNK01, and leveraging its clinical partners and donors’ network. Based in the US, NKGen develops and markets new autologous, allogeneic and CAR-NK NK cell therapies.
Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent.
Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. Specific scan conditions and safety information are provided in the Evoke ® SCS System MRI Guidelines manual. Are you hiring?
a privately held company that is developing innovative therapies in endovascular embolization, is pleased to announce it has received FDA Premarket Approval (PMA) of its Lava® Liquid Embolic System (Lava® LES) for treatment of peripheral arterial hemorrhage. Bay Area-based BlackSwan Vascular, Inc.,
Food and Drug Administration (“FDA”) for Cresilon Hemostatic Gel (“CHG ”). This marks Cresilon’s first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company’s global mission to transform wound care. ” said Cresilon CEO and Co-Founder Joe Landolina.
“ IntelliMammo also provides Desert Imaging with comprehensive FDA Mammography Quality Standards Act (MQSA) EQUIP workflows and on-demand report generation that provides a framework for continuous quality improvement that aggregates and presents quality indicators across their sites, and supports ACR/MQSA compliance.
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Rapid Medical , a leading developer of advanced neurovascular devices, announces FDA 510(k) clearance for TIGERTRIEVER 13 for large vessel occlusions at the 2022 Society of NeuroInterventional Surgery’s (SNIS) 19th Annual Meeting in Toronto. The ability to tailor each procedure can provide new safety levels for higher-risk thrombectomies.
Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to initiate a pilot trial of the eShunt ® System in patients who develop communicating hydrocephalus post aneurysmal subarachnoid hemorrhage (paSAH). . CereVasc, Inc., Press Release by: CereVasc. Are you hiring?
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Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical.
Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.
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