Germany Introduces Nutri-Score Front-of-Package Labeling

2021 ◽  
Vol 2021 (2) ◽  
Keyword(s):  
Package Labeling

Direct-to-Consumer Prescription Drug Advertising

1999 ◽  
Vol 25 (1) ◽  
pp. 149-167
Author(s):  
Tamar V. Terzian
Keyword(s):  
Prescription Drug ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmaceutical Products ◽  
Drug Advertising ◽  
Direct To Consumer ◽  
Prescription Drug Advertising ◽  
Adequate Provision ◽  
Package Labeling ◽  
Made In

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products. The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made “in connection with the broadcast presentation,” if the brief summary is not also part of the advertisement. Under the FDCA, the brief summary provides information concerning the major risks of the drug.

Regulating Front of Package Labeling: An Exercise in Futility?

2011 ◽  
Vol 6 (4) ◽  
pp. 513-523 ◽  
Author(s):  
Andy Bellatti ◽  
Michele Simon
Keyword(s):  
Package Labeling

Evaluation of mobilization efficacy with an extended interval following plerixafor administration

2020 ◽  
Vol 26 (7) ◽  
pp. 1590-1597
Author(s):  
Sarah E Stump ◽  
Morgan Trepte ◽  
J Ryan Shaw ◽  
Tatjana Grgic ◽  
Jonathan R Ptachcinski ◽  
...  
Keyword(s):  
Stem Cell ◽  
Primary Outcome ◽  
Granulocyte Colony Stimulating Factor ◽  
Complete Collection ◽  
Hematopoietic Stem ◽  
Cd34 Cells ◽  
The Mean ◽  
Package Labeling ◽  
Stimulating Factor ◽  
Disease Specific

Plerixafor is a hematopoietic stem cell mobilizing agent used in combination with granulocyte-colony stimulating factor to improve collection for autologous stem cell transplantation. Despite a recommendation for administration 11 h prior to apheresis per package labeling, logistical challenges lead many institutions to administer plerixafor at an extended interval. The purpose of this study was to determine if plerixafor effectively and efficiently mobilizes CD34+ cells when given at an extended interval prior to apheresis. This was a retrospective evaluation of adult patients who received plerixafor based on an algorithm reserving daily plerixafor only for patients with a pre-apheresis CD34+ count of < 20 cells/µL (pre-apheresis plerixafor) or with a low CD34+ yield after the first apheresis session (rescue plerixafor). The primary outcome was achievement of a disease-specific collection goal of ≥ 6 ×106 CD34+ cells/kg for multiple myeloma and ≥ 4 ×106 CD34+ cells/kg for lymphoma. The mean interval between plerixafor administration and apheresis was 17 h in this study. Despite this extended interval, 64% of patients met their disease-specific collection goal. A minimum collection goal of ≥ 2 ×106 CD34+ cells/kg was achieved by 95% of patients. Mobilization remained efficient with a median of two days to complete collection. Based on this data, plerixafor effectively and efficiently mobilizes CD34+ cells when given at an extended interval prior to apheresis.

Nonprescription Medication Use by Infants and Children: Product Labeling Versus Evidence-Based Medicine

2006 ◽  
Vol 19 (5) ◽  
pp. 286-294 ◽  
Author(s):  
Katherine Kelly Orr ◽  
Kelly L. Matson ◽  
Brian J. Cowles
Keyword(s):  
Adverse Drug Events ◽  
Medication Use ◽  
Infants And Children ◽  
Health Care Practitioner ◽  
Efficacy Data ◽  
Over The Counter ◽  
The Past ◽  
Nonprescription Medication ◽  
Based Medicine ◽  
Package Labeling

Nonprescription or over-the-counter (OTC) medication use has been an increasing market over the past years. In addition to adult use of these medications, children also account for this trend. Although relatively safe when used according to package labeling and professional direction, serious adverse drug events and toxicity associated withOTC use among infants and children are becoming more common. The purpose of this review is to help the health care practitioner select and counsel on pediatric OTC products based on labeling and efficacy data in 3 main areas: cough and cold, analgesics, and treatment of gastroenteritis.

scholarly journals The Effects of Featured Advertising and Package Labeling on Sustainability of Cause-Related Marketing (CRM) Products

2018 ◽  
Vol 10 (9) ◽  
pp. 3011 ◽  
Author(s):  
Sunhee Choi ◽  
Sangno Lee ◽  
Wesley Friske
Keyword(s):  
Financial Performance ◽  
Competitive Advantage ◽  
Grocery Store ◽  
Natural Setting ◽  
Relative Efficacy ◽  
Scanner Data ◽  
Persuasive Message ◽  
Cause Related Marketing ◽  
Product Package ◽  
Package Labeling

This paper seeks to examine the relative efficacy of cause-related marketing (CRM) product package labeling versus featured advertising efficacy on market performance. One natural setting using scanner data from a grocery store chain and an open-ended survey were conducted to evaluate the financial performance of featured advertising and product labeling in terms of sustainability of cause-related marketing products. Our findings suggest that cause-related marketing product package labeling without featured advertising appears to provide a competitive advantage resulting in superior financial performance. Also, featured advertising without product package labeling boosts products sales. However, when featured advertising is applied to cause-related marketing product package labeling, the effect of such labeling is diminished. Based on our findings, we suggest that final and intermediate sellers of cause-related marketing products should deliver a persuasive message about the sustainability of cause-related marketing products in the context of a conspicuous environment (e.g., Facebook and Twitter). Although featured advertisements and product package labels are two of the most widely-used tools to promote cause-related marketing products, the cause-related marketing literature has largely neglected a meaningful comparison between the two. This paper seeks to fill the gap in the literature.

Error in epoprostenol package labeling

1996 ◽  
Vol 53 (10) ◽  
pp. 1195-1195
Author(s):  
Leigh A. Anderson
Keyword(s):  
Package Labeling
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