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“Q&A with FDA” is a monthly podcast series that provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Office of Drug Information will answer some of the most commonly asked questions received by FDA. Perhaps you have had the same questions

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As of September 1, 2016, the safety labeling changes (SLC) program will be managed by the Center for Drug Evaluation and Research’s (CDER’s) Office of Communications (OCOMM).

FDA recognizes that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom domperidone’s potential benefits may justify its potential risks. Patients 12 years of age and older with certain gastrointestinal (GI) conditions

FDA's Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

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Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.

Explore the FDA’s Regulatory Pharmaceutical Fellowship Program, a partnership with academia and industry, offering specialized training in regulatory science, policy, and drug development. Learn how to advance your career in the pharmaceutical field through this unique fellowship opportunity.

The article examines how earlier diagnosis and proactive eye care may help reduce long-term vision loss. RACINE, Wis., Sept. 7, 2026 /PRNewswire/ -- What is interventional eye care, and how is it changing treatment in Racine? HelloNation has published an article that answers this question...

HYDERABAD, India, Sept. 7, 2026 /PRNewswire/ -- According to Mordor Intelligence, the global snack bars market size is projected to grow from $21.94 billion in 2026 to $32.66 billion by 2031, registering a CAGR of 8.28% during the forecast period (2026-2031). Growth is being supported by...

The article outlines inspection timelines and compliance steps required to meet safety codes across Central Indiana. PLAINFIELD, Ind., Sept. 7, 2026 /PRNewswire/ -- How often do fire extinguishers need to be inspected and serviced in Central Indiana? HelloNation has published an article...

SHERIDAN, Wyo., Sept. 7, 2026 /PRNewswire/ -- The global stem cells market is on track to grow from an estimated USD 18.9 billion in 2026 to USD 32.57 billion by 2031, expanding at a CAGR of 11.5% over the forecast period (2026–2031), according to a new study by Wissen Research. Momentum...

Patients with locally advanced hepatocellular carcinoma (HCC) typically receive systemic therapy with an anti-PD-(L)1 antibody plus a VEGF targeted therapy, although these regimens are rarely curative. Now, data from the phase III TALENTOP trial demonstrate that liver resection following induction therapy with atezolizumab plus bevacizumab can improve survival outcomes in this setting. A total of 489 patients with previously untreated HCC with at least one measurable lesion with macrovascular invasion and no extrahepatic spread, Child–Pugh A liver function and a future liver remnant ratio of ≥25% received induction atezolizumab plus bevacizumab. A total of 208 patients had either stable disease or a partial response and were considered eligible for surgical resection. These patients were randomly assigned (1:1) to surgery followed by atezolizumab plus bevacizumab versus maintenance atezolizumab plus bevacizumab. Time to treatment failure (TTF), measured from randomization, was the primary end point. This is a preview of subscription content, access via your institution Access options

The community-acquired bacterial pneumonia market is poised for continued growth, driven by the substantial global disease burden, increasing hospitalization rates, an aging population, rising prevalence of comorbidities, and the growing challenge of antimicrobial resistance....

DELRAY BEACH, Fla., Sept. 7, 2026 /PRNewswire/ -- According to MarketsandMarkets™, the Laboratory Glassware Market is projected to reach USD 9,170 million by 2031 from USD 7,630 million in 2026, at a CAGR of 4.0% during the forecast period. Browse 350 market data Tables and 100 Figures...

CEO Ji-yong Yoon presents proprietary liposome validation framework: "Scientific validation should come before a product is labeled 'liposomal.'" As Korea's pioneer in commercializing liposomal health functional foods, Wooree Group aims to set new industry quality standards. Showcases an...

- First to demonstrate clinical utility of ring-type BP monitoring in AF and heart failure patients - Highlighted CART blood pressure monitor's multifaceted value, including ESH-based validation and sleep apnea tracking MUNICH and SEOUL, South Korea, Sept. 7, 2026 /PRNewswire/ -- Sky Labs...

Judge Overturns Kaneka's '080 Patent for Lack of Utility and Enablement, Removing Legal Uncertainty for Customers and Partners JIAXING, China, Sept. 7, 2026 /PRNewswire/ -- Cocrystal Technology (Jiaxing) Co., Ltd. ("Cocrystal Tech") today announced that the U.S. District Court for the...

– 5,600 participants from 19 countries discuss global bio innovation and the path forward – – Strengthened global regulatory cooperation, with a total of 23 meetings held with overseas regulators and industry, including 5 regulatory cooperation meetings – SEOUL, South Korea, Sept. 7, 2026...

Science and technology are turning fundamental research into the practical tools that reshape our daily lives. JUPITER, Fla., Sept. 7, 2026 /PRNewswire/ -- Advancements with Ted Danson will examine four areas of technological advancement during its upcoming broadcast on Saturday,...

HAMILTON, ONTARIO, 7. September 2026 /PRNewswire/ -- AtomVie Global Radiopharma (AtomVie), eine weltweit führende Contract Development and Manufacturing Organization (CDMO) in der Radiopharmazie, feierte heute die feierliche Eröffnung seiner neuen, eigens für diesen Zweck errichteten und...

HAMILTON, ONTARIO, 7 septembre 2026 /PRNewswire/ -- AtomVie Global Radiopharma (AtomVie), une organisation de développement et de fabrication sous contrat (CDMO) de premier plan à l'échelle mondiale dans le secteur des radiopharmaceutiques, a célébré aujourd'hui l'inauguration officielle...

NEW YORK, Sept. 7, 2026 /PRNewswire/ -- Consumer365 has named Happy Head its 2026 choice for personalized minoxidil formulas for women, examining how prescription hair-loss care can be adapted by age, medical history, hair-loss pattern, and preferred delivery method. Best Minoxidil for...

First-in-Class Evaluation of an AI-Driven Candidate: This is the first de-novo drug designed with generative AI for a de-novo target discovered using AI and Aging Research (AI aging clocks, AI models and Hallmarks of Aging Assessment). First Universal Consensus Across Six...

Rating Improves for Third Consecutive Year, Ranking Among Top 10% of Financials, Demonstrating Strong Sustainability Performance HONG KONG and SHANGHAI, Sept. 7, 2026 /PRNewswire/ -- Ping An Insurance (Group) Company of China, Ltd. ("Ping An" or the "Group"; HKEX: 2318; SSE: 601318) has...

Rating Improves for Third Consecutive Year, Ranking Among Top 10% of Financials, Demonstrating Strong Sustainability Performance HONG KONG and SHANGHAI, Sept. 7, 2026 /PRNewswire/ -- Ping An Insurance (Group) Company of China, Ltd. ("Ping An" or the "Group"; HKEX: 2318; SSE: 601318) has...

Nachweis des klinischen Nutzens der ringbasierten Blutdrucküberwachung bei Patienten mit Vorhofflimmern und Herzinsuffizienz Vielseitige Einsatzmöglichkeiten des CART-Blutdruckmessgeräts hervorgehoben: ESH-Validierung und Überwachung von Schlafapnoe MÜNCHEN, Deutschland und SEOUL,...

First comprehensive systematic review provides insights into the long-term safety profile of angiogenic approaches in coronary artery disease Data shows no evidence of increased cancer or retinopathy, resolving long-standing safety questions that have limited progress across the field...

BERLIN, Sept. 7, 2026 /PRNewswire/ -- Home fitness has traditionally been a solitary experience. At IFA Berlin 2026 this week, DeerRun is showing how connected equipment and digital experiences can turn individual workouts into shared activity. Through September 8, visitors can explore...

- First to demonstrate clinical utility of ring-type BP monitoring in AF and heart failure patients - Highlighted CART blood pressure monitor's multifaceted value, including ESH-based validation and sleep apnea tracking MUNICH and SEOUL, South Korea, Sept. 7, 2026 /PRNewswire/ -- Sky Labs...

Démonstration inédite de l'efficacité clinique de la surveillance de la pression artérielle par bague connectée chez les patients atteints de fibrillation auriculaire et d'insuffisance cardiaque Mise en évidence des multiples avantages du tensiomètre CART : validation selon les critères...

Demostración inédita de la utilidad clínica de la monitorización de la presión arterial mediante un anillo inteligente en pacientes con fibrilación auricular e insuficiencia cardíaca Puesta en valor de la versatilidad del monitor CART: validación según los criterios de la ESH y...

YANTAI, Chine, 7 septembre 2026 /PRNewswire/ -- CelluPro, une entreprise de biotechnologie spécialisée dans les milieux de culture cellulaire sans sérum et les solutions de bioprocédés, a obtenu la certification EXCiPACT™ GMP pour les matières auxiliaires pharmaceutiques (PAM), devenant...

YANTAI, China, 7. September 2026 /PRNewswire/ -- CelluPro, ein auf serumfreie Zellkulturmedien und Bioprozesslösungen spezialisiertes Biotechnologieunternehmen, hat die EXCiPACT™-GMP-Zertifizierung für pharmazeutische Hilfsstoffe (PAMs) erhalten und ist damit der erste chinesische...

MELBOURNE, Australia, Sept. 7, 2026 /PRNewswire/ -- Nutromics, a Melbourne-based startup leading the frontier of DNA-based sensing, has announced the appointment of Professor Kevin W. Plaxco as Chief Scientific Officer (CSO). The company is preparing for the launch of its first product in...

GENEVA, Sept. 7, 2026 /PRNewswire/ -- The International Organization for Standardization (ISO) has today launched ISO 45010 - Occupational health and safety management — Menstruation and menopause in the workplace — Guidance, the world's first International Standard providing guidance to...

SEONGNAM, South Korea, Sept. 6, 2026 /PRNewswire/ -- Rznomics Inc.(KOSDAQ: 476830), a biopharmaceutical company specializing in the development of RNA-based gene therapies, announced a major breakthrough in the high-efficiency production of circular RNA (circRNA) – a rapidly emerging...

HONG KONG, Sept. 7, 2026 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that, the ordinary shares of the Company (the "Shares"), which trade on The Stock Exchange of Hong Kong Limited (the "HK Stock Exchange"), have been included in the list of eligible securities...

Interim MASTRR Registry analysis represents, to Aroa's knowledge, the largest published prospective bioscaffold analysis in in-patient soft tissue reconstruction AUCKLAND, New Zealand, Sept. 6, 2026 /PRNewswire/ -- Aroa Biosurgery Limited (ASX: ARX), a soft tissue regeneration company,...

The growing population of cancer survivors is increasingly exposed to the long-term risk of second primary cancers (SPCs), which represents a major source of morbidity and mortality. While current prevention mainly relies on surveillance and screening, pharmacological and immunological strategies may offer opportunities to reduce SPC incidence in selected high-risk populations.

Curative R0-R1 resection is not always feasible in patients with extensive bilobar colorectal liver metastases (CRLM). When unresectatility is confirmed, the standard of care is palliative chemotherapy or more recently liver transplantation (LT) with very restrictive eligibility criteria. This exploratory study evaluated cytoreductive surgery as an alternative to chemotherapy alone in patients with initially unresectable CRLM responding well to systemic chemotherapy but ineligible to LT.

Extrapulmonary neuroendocrine carcinomas (epNECs) are high-grade malignancies that arise from various anatomic sites and follow an aggressive clinical course. Most patients with epNEC present with metastatic disease at diagnosis and face a dismal prognosis, surviving less than a year. Despite treatment, disease progression is common and most patients rapidly succumb to the disease, which may limit participation in prospective clinical trials. Given the grim survival outcomes, in addition to the rarity and heterogeneity of the disease, high-quality data are lacking and epNECs remain poorly understood.

Advances in hepatocellular carcinoma (HCC) treatment and patient profiling are driving a shift toward personalized, multimodality management. The enhanced efficacy of locoregional therapies (LRTs) and systemic regimens has expanded treatment options across palliative and curative settings. For patients eligible to curative-intent treatment, adjunctive approaches aim to enhance procedural feasibility and optimize patient outcomes. Bridging and downstaging to liver transplantation, while traditionally relying on intra-arterial therapies are now seeing emerging alternatives such as stereotactic body radiotherapy (SBRT) and systemic agents.

The standard of care (SoC) for locally-advanced (LA) head and neck squamous cell carcinoma (HNSCC) has remained relatively unchanged for decades, usually consisting of multimodal treatment that can include surgery, radiotherapy, and systemic therapy. Survival rates are low, so there is a key unmet need to improve clinical outcomes. Immune checkpoint inhibitors (ICIs), including anti-programmed cell death protein-1 (PD-1) agents, redefined the SoC for recurrent/metastatic HNSCC, and based on recent positive outcomes in Phase III studies, the SoC for resectable LA-HNSCC has evolved to include ICI-based therapy; however, key challenges remain.

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, Sept. 6, 2026 /PRNewswire/ -- Today, shares of Harbour BioMed (the "Company"; HKEX: 02142.HK) were officially included in the eligible shares list of the Stock Connect. Effective immediately, qualified investors in mainland China can...

-- Positive Phase 2 (Australia) results strengthen potential best-in-class profile of RSV+hMPV±PIV3 combination vaccines, with the potential differentiated ability to re-vaccinate individuals previously receiving approved RSV vaccines to restore and broaden protection -- -- Robust...

SHANGHAI, Sept. 6, 2026 /PRNewswire/ -- Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma", stock code: 600196.SH; 02196.HK) today announced an H-share repurchase plan, under which the company intends to repurchase its H-shares with an aggregate amount of up to HK$1 billion....