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Nicotine-Containing Products
… therapy (NRT) products, which are currently approved as aids to smoking cessation. In addition, HHS has submitted a report to …
Center for Drug Evaluation and Research 2002
… Internet sites, the products were being promoted as aids for smoking cessation or to treat nicotine addiction. According to …
Spectrum of Diseases/Conditions
… with alcohol dependency Neonatal abstinence syndrome (NAS) Smoking cessation Allergy Type I/II hereditary angioedema … Mellitus Type 1 Type 2 Failure to thrive in pediatric AIDS patients Growth-hormone-secreting lesions of the …
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
… 15011dft.docx 01/24/19 Smoking Cessation and Related Indications: Developing Nicotine … Currently, all approved NRT drug products are indicated as aids to smoking cessation. Some 219 NRT drug products could …
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products
… Smoking Cessation and Related Indications: Developing Nicotine … Evaluation and Research (CDER) May 2023 Clinical/Medical Smoking Cessation and Related Indications: Developing … Currently, all approved NRT drug products are indicated as aids to smoking cessation. Some sponsors of NRT drug products …
FDA and the Internet: Advertising and Promotion of Medical Products - Discussion Group 1
… Medical Journalist Kiyoshi Kuromiya, Critical Path AIDS Project Thomas Merchant, SmithKline Beecham Peter … I'm Dave Vance, attorney for HIV, oncology, dermatology, smoking cessation, depression and a whole bunch of other areas at …
Coronavirus Disease 2019 (COVID-19)
… Today, the FDA issued a final guidance for industry titled Smoking Cessation and Related Indications: Developing Nicotine … the FDA issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. …
CTP - Report to Congress - Section 918
… 1 Section 918 was added to the FD&C Act by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco … the approval of medical products to bring about cessation (quitting) in individuals who currently use tobacco … approved by FDA for tobacco dependence were approved as aids to smoking cessation. There are currently five types of …
386_021928S48 varenicline unireview both
… N/A Applicant Proposed Indication(s)/Population(s) Aid to smoking cessation treatment in adults Recommendation on Regulatory … tartrate) 4 Table of Tables Table 1 Drugs Used as Aids to Smoking Cessation …
Best Practices in Risk Communication and Communicating Uncertainty: Applications to FDA-Regulated Products
… blood test) McClure JB. Are biomarkers useful treatment aids for promoting health behavior change? An empirical … Communication and Biomarkers Do lifestyle behaviors (e.g., smoking, physical activity, diet) change when people are … Bull. 2006; 132(2): 249–68. 5 Empirical Evidence Smoking cessation most studied behavior Over 30 years of evidence …
The "Promise" of Biomarker Feedback as a Risk Communication Strategy to Promote Health Behavior Change
… blood test) McClure JB. Are biomarkers useful treatment aids for promoting health behavior change? An empirical … Communication and Biomarkers Do lifestyle behaviors (e.g., smoking, physical activity, diet) change when people are … Bull. 2006; 132(2): 249–68. 5 Empirical Evidence Smoking cessation most studied behavior Over 30 years of evidence …
Pfizer Briefing Information for the September 14, 2016 Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
… 1.3. Importance of Smoking Cessation Therapies: Health Burden of Smoking ............19 … bupropion, nicotine replacement therapy, or placebo as aids to smoking cessation over 12 weeks of treatment, and to …
Shoben Abigail CV 2021
… (2016). “Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10 School Trial: A Randomized, … Use After Participation in a Community-Based Tobacco Cessation Trial." Nictotine Tob Res. 20(1): 135-139. 34. … Sex Workers in Malawi: A Discrete Choice Experiment.” AIDS Behav. 24(5): 1294-1303. 67. Ilacqua A, Benedict J, …
Blood Products Advisory Committee Curriculum Vitae Adaora Adimora
… APPOINTMENTS: 2020 – Present Co-Director, UNC Center for AIDS Research 2018 – Present Sarah Graham Kenan Distinguished … Cohen MH, Tien PC, Taylor TN, Anastos K, Adimora AA. A new smoking cessation 'cascade' among women with or at risk for HIV …
Abigail B. Shoben Curriculum Vitae
… (2016). “Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10 School Trial: A Randomized, … Use After Participation in a Community-Based Tobacco Cessation Trial." Nictotine Tob Res. 20(1): 135-139. 34. … Sex Workers in Malawi: A Discrete Choice Experiment.” AIDS Behav. 24(5): 1294-1303. 67. Ilacqua A, Benedict J, …
Curriculum Vitae: Abigail B. Shoben
… (2016). “Teaching Medical Students to Help Patients Quit Smoking: Outcomes of a 10 School Trial: A Randomized, … Use After Participation in a Community-Based Tobacco Cessation Trial." Nictotine Tob Res. 20(1): 135-139. 34. … Sex Workers in Malawi: A Discrete Choice Experiment.” AIDS Behav. (In Press). 67. Ilacqua A, Benedict J, Shoben A, …
TPSAC - UCSF TCORS - Swedish Match
… is found in comparable populations with higher cigarette smoking rates. The MRTPA was based on the proposition that if … about the health risks of using the product relative to cessation aids; and • Consumer beliefs about the risks of using the …
Tobacco Product Application Review: Modified Risk Tobacco Product Applications (MRTPAs): Ben Apelberg – OS/Division of Population Health Science
… the risks of the product compare to: never use? cigarette smoking? other products in tobacco product category? • How do … to: continued smoking? quitting altogether? FDA-approved cessation aids? • Is there any evidence of the potential for reduced …
CTP TPSAC - Scout - CV
… Project. Through this led a national multi-city LGBT cessation research project, in collaboration with two other … in hostile media. 1988-92 Development Associate, AIDS Foundation of Chicago. Chicago IL • One of two … D, Baker K, Scout NFN, Karekla M. An Avatar-Led Digital Smoking Cessation Program for Sexual and Gender Minority …
USSTC-TPL-MR0000108.pdf
… which is an acceptable approach. Compared to cigarette smoking, ST use poses lower risks of certain health outcomes. … for the proposed MRTP is greater than use of FDA-approved cessation aids, but less than that associated with cigarette smoking. …
fda-ctp-2023-strategic-plan.pdf
… commitment to implementing the components of the Family Smoking Prevention and Tobacco Control Act, while adapting to … the risks of using tobacco products and the benefits of cessation. of Science, Office of Health Communication and … n Work to provide scientific reviewers with updated job aids/reviewer guides to support scientific reviewers and to …
Tobacco Products Scientific Advisory Committee Meeting January 24-25, 2018: Transcript Day 1
… Maryland 20857 BRIAN KING, Ph.D., M.P.H. Office on Smoking and Health (OSH) National Center for Chronic Disease … everything from cigarettes to FDA-approved smoking cessation aids, like the nicotine gum, patch, and lozenge. FDA's …
TPSAC February 6-7 2019 Applicant Briefing Document-Swedish Match Amendment
… along with low likelihood of decreased and/or delayed cessation. 2. Perceptions and Behavioral Intentions Study for … which specified the health conditions associated with smoking that are mitigated by switching to General Snus, had … to daily use of other tobacco or nicotine products, aids to stop smoking, both cigarettes and General Snus, never …
GDUFA III Public Meeting Fall 11.16.21
… colitis 6/1/2021 Varenicline Tablets Chantix Tablets Smoking cessation 8/11/2021 Linagliptin Tablets Tradjenta Tablets … review programs under the President’s Emergency Plan for AIDS Relief (PEPFAR) U.S. Food and Drug Administration | …
GDUFA III Fall Public Meeting 11 16 2021 slides
… colitis 6/1/2021 Varenicline Tablets Chantix Tablets Smoking cessation 8/11/2021 Linagliptin Tablets Tradjenta Tablets … review programs under the President’s Emergency Plan for AIDS Relief (PEPFAR) 29 GDUFA III Enhancements - Improving …