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Filtering on: "topics nutritional and dietary supplements"

Showing 1 – 25  of 51

FDA Warns LA-Based Medical Food Company for Clinical Trial Without an IND By Zachary Brennan - Published 18 April 2017

The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.

Categories: News, US, FDA, Clinical, Compliance, Crisis management, Nutritional and dietary supplements, Research and development

Tags: warning letter, LA medical foods, medical food clinical trial

Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016) By Nick Paul Taylor - Published 08 November 2016

China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Generic drugs, Medical Devices, Nutritional and dietary supplements, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Health Canada Looks to Raise the Bar for Regulating Natural Health Products By Zachary Brennan - Published 04 October 2016

A controversial new proposal from Health Canada would add new regulatory scrutiny for natural health products and bring them in line with higher scientific standards used to regulate over-the-counter drugs.

Categories: News, Canada, Health Canada, Cosmetics, Over the counter drugs, Nutritional and dietary supplements

Tags: Health Canada, natural health products, cosmetics, OTC drugs, non-prescription drugs

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

Nutrition, Health and Disease Management, Hot Topics and a Preview of September By Gloria Hall - Published 01 September 2016

The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together.

Categories: Features, News, Nutritional and dietary supplements

Tags: Food, Medical foods, Nutrition, Dietary supplements, FSMA

Surviving Your First FSMA Inspection By Joseph A. Levitt, Maile Gradison Hermida, Elizabeth Barr Fawell - Published 01 September 2016

This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices.

Categories: Features, US, FDA, Manufacturing, Nutritional and dietary supplements

Tags: FSMA, Food Safety Modernization Act, Inspections

Medical Foods: Guidelines for Development and Usage By Elizabeth J. Johnson, PhD, Junaidah B. Barnett, PhD, Simin N. Meydani, DVM, PhD - Published 01 September 2016

This article presents the definition of medical foods, applicable regulations and the clinical trials process, including issues pertaining to study design, institutional review boards, study participants, trial managers responsibilities toward participants, data analysis and peer review.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Medical Foods

EMA to Revise Herbal Medicines Guideline By Zachary Brennan - Published 01 September 2016

The European Medicines Agency (EMA) on Thursday opened for public comment a draft revision to its scientific guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicines.

Categories: News, Europe, EMA, Nutritional and dietary supplements

Tags: herbal medicine, EMA guidance

The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food By James Hoadley - Published 31 August 2016

This article presents FDA's regulatory framework for food for human consumption and how the various legislation regarding information about nutritional content and health-related aspects of food should be presented on food labels.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Foods, Medical foods, Dietary supplements

Targeted (Personalized) Nutrition By Jim Kaput, Colleen Draper, Patrick Descombes, Serge Rezzi, Martin Kussmann - Published 26 August 2016

This article discusses the latest omics technology developments, focusing on genomics, proteomics and nutritional (metabolic) profiling and presents the main challenges for targeted nutrition and regulatory issues related to omics technologies.

Categories: Features, FDA, Nutritional and dietary supplements

China Food Safety Regulatory Framework By Dr. Junshi Chen - Published 25 August 2016

This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed.

Categories: Features, China, CFDA, Nutritional and dietary supplements

Tags: Food Safety

Genetically Engineered Foods and their Regulation: the Way Forward after Twenty Years of Adoption By Gregory Jaffe - Published 24 August 2016

This article reviews the US history and impact of Genetically Engineered (GE) crops over two decades, explains the federal oversight of GE crops and suggests improvements to federal oversight to ensure the safety of GE crops and greater consumer confidence in GE foods. The article also discusses public attitudes toward GE foods and the issues surrounding the labeling of those foods, including the law requiring mandatory disclosure signed by President Obama on 29 July 2016.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Genetically Engineered Foods, GE Foods

Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims By Andrea W. Wong, PhD - Published 17 August 2016

This article discusses claim categories for dietary supplements and recent related regulatory development and enforcement activity to help those who market dietary supplements understand the evolving regulatory climate, legalities and substantiation requirements.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Dietary Supplements, Nutrient Content, Recommended Dietary Allowances

International Food Regulatory Framework: the Codex Alimentarius Commission By Awilo Ochieng Pernet - Published 12 August 2016

This article reviews the mission of the of the Codex Alimentarius Commission (CAC), an international body whose mandate is to develop internationally harmonised food safety and quality standards to protect the health of consumers and ensure fair practices in the food trade.

Categories: Features, Nutritional and dietary supplements

Tags: Codex Alimentarius Commission

Medical Foods Intended to Meet Distinctive Nutritional Requirements: Scientific and Regulatory Perspective By Josy Giordano-Schaefer, Jane Durga, Fernando Henrique Xavier de Brito, Heinrich Schneider - Published 10 August 2016

This article proposes an algorithm for investigating Distinctive Nutritional Requirements (DNRs) with the goal of guiding research and supporting the development of innovative medical food products to improve quality of care for patients.

Categories: Features, US, FDA, Nutritional and dietary supplements

Tags: Medical foods

Petition Calls on FDA to Pull All Fluoride Supplements From the Market By Zachary Brennan - Published 18 May 2016

The Fluoride Action Network (FAN) and the International Academy of Oral Medicine & Toxicology (IAOMT) are calling on the US Food & Drug Administration (FDA) to expedite the removal from the market all unapproved, unsafe, unnecessary and ineffective sodium fluoride-containing drops, tablets and lozenges sold for the intended purpose of preventing tooth decay.

Categories: News, US, FDA, Nutritional and dietary supplements, Product withdrawl and retirement

Tags: fluoride, fluoride supplements, Walmart, Walgreens, CVS, Rite Aide

Regulatory Recon: FDA Staff Question New Lung Cancer Drug (8 April 2016) By Zachary Brennan - Published 08 April 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, CDSCO, EC, EMA, FDA, MHLW, PMDA, Audit, Biologics and biotechnology, Business Skills, Clinical, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Nutritional and dietary supplements

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Updated: European Commission: Cranberry-Derived Products are not Medical Devices By Zachary Brennan - Published 23 February 2016

The European Commission has released a draft decision that would mean the group of products depending on proanthocyanidins present in cranberry (Vaccinium Macrocarpon) extract, in order to prevent or treat cystitis, also known as bladder inflammation or infection, should not be classified as medical devices.

Categories: News, Europe, EC, Active pharmaceutical ingredients, Crisis management, Government affairs, Nutritional and dietary supplements, Product withdrawl and retirement, Research and development

Tags: cranberry products, UTIs, urinary tract infections, Medical Brands, ANSM

FDA Unveils New Office of Dietary Supplement Programs By Zachary Brennan - Published 21 December 2015

As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP).

Categories: News, US, FDA, Compliance, Distribution, Government affairs, Nutritional and dietary supplements, Quality

Tags: dietary supplements, supplement regulation, FDA and dietary supplements

A Brighter Future for Regulatory Professionals Published 15 December 2015

Regulatory Focus (RF) Interviews Bird Shi, Regional Regulatory Affairs Director, Abbott Nutrition, Greater China.

Categories: Features, Asia, CFDA, Government affairs, Nutritional and dietary supplements

Tags: Abbott, Food regulations

Three Asian Companies Banned From Sending Imports to the US by FDA By Zachary Brennan - Published 04 December 2015

China-based Jinan Jinda Pharmaceutical Chemistry Co., Zhejiang Qianfei Enterprise Co. and Hong Kong-based Chan Yat Hing Medicine Factory were added to the US Food and Drug Administration’s (FDA) import alert list over the last two weeks, effectively banning the companies from shipping products to the US.

Categories: Active pharmaceutical ingredients, Compliance, Cosmetics, Crisis management, Distribution, Drugs, Government affairs, Manufacturing, Nutritional and dietary supplements, Postmarket surveillance

Tags: import alert, China pharmaceutical manufacturing, pharmaceutical distribution, China imports

US Government Agencies Crack Down on Dietary Supplement Manufacturers By Zachary Brennan - Published 17 November 2015

In partnership with the Department of Justice, Federal Trade Commission and other agencies, the US Food and Drug Administration (FDA), announced that after a yearlong sweep of dietary supplement makers, the agencies have filed civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements.

Categories: News, China, US, DOJ, FDA, FTC, Compliance, Distribution, Manufacturing, Nutritional and dietary supplements

Tags: USPlabs, FDA, DOJ, FTC, dietary supplements, nutraceuticals, good manufacturing practices

FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly By Zachary Brennan - Published 10 November 2015

Sen. Claire McCaskill (D-MO) is calling on ten major nutritional supplement retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Active pharmaceutical ingredients, Distribution, Drugs, Nutritional and dietary supplements, Product withdrawl and retirement, Regulatory intelligence

Tags: picmilon, Google, Amazon, Vitamin World, GNC, Claire McCaskill, nutritional supplements, dietary supplements, pharmaceutical ingredients

FDA Bans Pharma, Nutraceutical and Cosmetic Imports from Canadian Company By Zachary Brennan - Published 29 September 2015

The US Food and Drug Administration (FDA) has added Canada's Cosmetic Manufacturers Inc. (CMI) to a list of companies that have been banned from shipping products to the US.

Categories: News, Canada, US, FDA, Cosmetics, Drugs, Nutritional and dietary supplements, Quality, Regulatory intelligence, Regulatory strategy

Tags: Cosmetic Manufacturers Inc., Canada pharmaceuticals, FDA import alerts, import alert list

Regulatory Recon: FDA Nominee Califf's Ties to Industry Worry Some (21 September 2015) Published 21 September 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, EMA, FDA, TGA, Drugs, Government affairs, In vitro diagnostics, Medical Devices, Nutritional and dietary supplements, Regulatory intelligence, Regulatory strategy

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News