Skip to content (Press Enter)
SG Logo Clr Trnsp 1

FDA Compliance Made Easy

+1(866)785-0873
  • Home
  • About
  • FDA Legal Services
    • FDA Consultant Services
    • Ingredient Reviews
    • FDA Label Reviews
    • FDA Imports
    • Supplement Facts Panels
    • Outer Packaging Requirements
    • Website Reviews
    • FDA Label Reviews and Marketing Reviews
    • FDA Consultant Food Services
    • Nutrient Content Claims
    • Organic and Natural Claims
    • Dietary Supplement Consultant and Attorney Services
    • Structure Function Claims
    • Disease Claims
    • Health Claims
    • FDA Warning Letter Responses
    • 30-Day Notification – Dietary Supplements
    • Premarket Approval
    • 510k / Premarket Clearance
  • Food & Drug Blog
    • FDA Untitled Letters: FDA Warnings with a Twist
    • FDA Regulation of Aromatherapy and Essential Oil Products
    • FDA Warning Letter Responses
    • Cosmetic Products and the FDA
    • FDA Imports: Tradeoff — Less Vigilance for More Diligence
    • District Court sides with Industry on Dietary Supplement Substantiation
    • FDA “Natural” Food Labeling
    • FDA Clears Device via De Novo Process
    • What’s in a Name? Everything, for “Standard” FDA Food Labeling
    • FDA Bans Trans Fats
    • FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations
    • Potential Changes to FDA Regulation of Homeopathic Drugs
    • US Marshals Seize Topical Products Deemed Drugs by FDA
    • Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics
    • FDA Warns of Marketing Cosmetics with Drug Claims
  • Contact Us
  • Home
  • About
  • FDA Legal Services
    • FDA Consultant Services
    • Ingredient Reviews
    • FDA Label Reviews
    • FDA Imports
    • Supplement Facts Panels
    • Outer Packaging Requirements
    • Website Reviews
    • FDA Label Reviews and Marketing Reviews
    • FDA Consultant Food Services
    • Nutrient Content Claims
    • Organic and Natural Claims
    • Dietary Supplement Consultant and Attorney Services
    • Structure Function Claims
    • Disease Claims
    • Health Claims
    • FDA Warning Letter Responses
    • 30-Day Notification – Dietary Supplements
    • Premarket Approval
    • 510k / Premarket Clearance
  • Food & Drug Blog
    • FDA Untitled Letters: FDA Warnings with a Twist
    • FDA Regulation of Aromatherapy and Essential Oil Products
    • FDA Warning Letter Responses
    • Cosmetic Products and the FDA
    • FDA Imports: Tradeoff — Less Vigilance for More Diligence
    • District Court sides with Industry on Dietary Supplement Substantiation
    • FDA “Natural” Food Labeling
    • FDA Clears Device via De Novo Process
    • What’s in a Name? Everything, for “Standard” FDA Food Labeling
    • FDA Bans Trans Fats
    • FDA Issues Tobacco Warning Letters for Tobacco Retailer Inspection Violations
    • Potential Changes to FDA Regulation of Homeopathic Drugs
    • US Marshals Seize Topical Products Deemed Drugs by FDA
    • Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics
    • FDA Warns of Marketing Cosmetics with Drug Claims
  • Contact Us

Tag: Gaucher disease

FDA Approves New Orphan Drug (Elelyso) to Treat Gaucher Disease

Drugs, FDA, Gaucher disease, Orphan Designation, Orphan DrugFDA

On May 1, 2012, the U.S. Food and Drug Administration (“FDA”) approved a new orphan drug to treat Gaucher disease. The drug, Elelyso (taliglucerase alfa), is an injection therapy used for enzyme replacement in people with the rare genetic disorder. …

Read More

Contact Us

Katherine L. Giannamore
Rated by Super Lawyers


loading ...

FDA Legal Services

  • 30-Day Notification – Dietary Supplements
  • 510k / Premarket Clearance
  • Dietary Supplement Consultant and Attorney Services
  • Disease Claims
  • FDA Consultant Services
  • FDA Imports
  • FDA Label Reviews
  • FDA Label Reviews and Marketing Reviews
  • FDA Registration and FDA Agent
  • FDA Warning Letter Responses
  • Food Consultant Services
  • Health Claims
  • Ingredient Reviews
  • Nutrient Content Claims
  • Organic and Natural Claims
  • Outer Packaging Requirements
  • Premarket Approval
  • Structure Function Claims
  • Supplement Facts Panels
  • Website Reviews

Read Our Blog

  • FDA
  • FTC
  • Uncategorized
  • USDA

Tags

510(k) Adverse Events Allergens Beverages CDRH CGMP Cosmetics Dietary Supplements Disease Claims Drug Drugs Enforcement FDA Food Food Facility Registration Food Safety Modernization Act FSMA FTC Gluten-Free GRAS Guidance imports Injunction Labeling Listeria mad cow Medical Devices NDA Nutrition Facts off-label promotion off-label use Orphan Designation Orphan Drug PMA post-marketing studies Recalls Rulemaking Salmonella Structure-Function Claims Substantiation Tobacco Control Act Tobacco Products Tobacco Warning Letter USDA Warning Letters

FDA Legal Topics

510(k) Adverse Events Allergens Beverages CDRH CGMP Cosmetics Dietary Supplements Disease Claims Drug Drugs Enforcement FDA Food Food Facility Registration Food Safety Modernization Act FSMA FTC Gluten-Free GRAS Guidance imports Injunction Labeling Listeria mad cow Medical Devices NDA Nutrition Facts off-label promotion off-label use Orphan Designation Orphan Drug PMA post-marketing studies Recalls Rulemaking Salmonella Structure-Function Claims Substantiation Tobacco Control Act Tobacco Products Tobacco Warning Letter USDA Warning Letters

Contact Us

Recent Posts

  • FDA Halts Voluntary Cosmetic Registrations Amidst Overhauls      
  • Congress Increases Minimum Tobacco Sales Age to 21
  • FDA Warns JUUL, Alleging Marketing Violations
  • FDA Warning Letters for Alzheimer’s Supplement Claims
  • FDA Considers Changing Major Food Allergen Labeling Requirements
cookie free hit trackers
 Lawyer Landing Page | Developed By Rara Theme. Powered by WordPress.
The owner of this website has made a commitment to accessibility and inclusion, please report any problems that you encounter using the contact form on this website. This site uses the WP ADA Compliance Check plugin to enhance accessibility.