This blog post was written by Gerhard Koenig, CEO of Arkuda Therapeutics, as part of the From The Trenches feature of LifeSciVC. When I discussed the topic of writing about my experience as an immigrant biotech CEO with Bruce Booth,

The post Reflections of an Immigrant CEO  appeared first on LifeSciVC.

This blog was written by Andrea DiMella, VP and Head of Talent at Atlas Venture, as part of the From The Trenches feature of LifeSciVC. What a difference a little time makes. When Bruce originally encouraged me to be a

The post Running Rehab: Managing Talent In A Pandemic appeared first on LifeSciVC.

This blog was written by Rene Russo, CEO of Xilio Therapeutics, as part of the From The Trenches feature of LifeSciVC. In an environment where senior leaders are tasked with defining agile strategies in uncertain times, there are many perspectives

The post Long-Range Planning (LRP): Reframed Leaders Require Purpose appeared first on LifeSciVC.

BASF recently announced the launch of Accelon™ absorption accelerating technology, developed as a breakthrough solution to the bioavailability challenge of today’s omega-3 supplements.

Valensa International announced today a joint venture agreement between Valensa’s parent company EID Parry and Synthite Industries Ltd., expanding plans to lead development and distribution of value-added microalgae extracts.

Baby Boomers, Gen X and Millennials are key consumer target groups for marketers, with three different sets of needs and buying propensities; it’s important that brands define their unique selling propositions.

The American Herbal Products Association submitted nearly 100 pages of comments to the Food and Drug Administration Center for Food Safety and Applied Nutrition identifying ways to improve regulations, guidance documents and enforcement practices to better protect public health.

At Engredea 2018 in March in Anaheim, CA, OmniActive will be highlighting the latest addition to its ginger ingredient range, Gingever 10% powder, expanding its application to tablets, capsules and beverages.

Selling directly to health care practitioners, supplement companies can foster open dialogue about their products; but, every regulation applies to products in this channel, too.

Nutrition 21, LLC has announced its Nitrosigine® is now featured in EVERTRAIN PRE, a recently launched pre-workout supplement designed to provide athletes with sustained energy, superior focus and increased endurance.

innoVactiv announces today its study supporting the efficacy of InSea2® to beneficially affect post-meal cognition and mental energy has been accepted for publication.

In this SupplySide West edition of the Healthy INSIDER podcast, Rachel Adams, managing editor, and Scott Steinford, founder and CEO of Trust Transparency Consulting, discuss the role of transparency in establishing trust with supplements consumers.  

Valensa International announced Non-GMO Project has been awarded to Valensa’s Organic Spirulina, Chlorella and Microalgae products.

Emphasis on fat and protein intake, reduced carbohydrate intake and gut health for managing weight are trends affecting the global weight management category.

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.

Bergstrom Nutrition, manufacturer of OptiMSM®, a branded form of methylsulfonylmethane (MSM), recently published an article detailing how the small intestine absorbs MSM, particularly in relation to sulfur.

The Organic Trade Association and The Organic Center on Thursday applauded Senators Bob Casey (D-PA) and Susan Collins (R-ME) for introducing The Organic Agriculture Research Act of 2018.

Emport LLC is pleased to introduce new training programs and materials to augment its food safety and allergen control portfolio.

Applied Food Sciences, Inc. (AFS) takes the next step in demonstrating complete transparency by getting four of its core ingredients Non-GMO Project Verified.

The Council for Responsible Nutrition announced the launch of a consumer education initiative designed to raise awareness of Selective Androgen Receptor Modulators, a dangerous class of ingredients.

The chief executive of a supplement company under investigation by FDA could go to prison for allegedly violating the terms of his supervised release following a criminal conviction in 2014.

Potential brain health benefits of cannabidiol (CBD) can make it an attractive ingredient for supplement brands, but federal regulations and FDA action may hinder product success in the market.

The cognitive-boost market just received another potent supplement ingredient–Quantum IQ Polygonum minus extract, exclusively from HP Ingredients, Inc. (HPI).

A doctor, researcher and former chronic migraine sufferer, has launched her own biotech startup company named KetoSwiss selling supplements that she argues can help control migraine pain by tapping into our own biological mechanisms.

Outside influences have shown strong correlations with what lives inside our bodies, and researchers are just beginning to understand how these environmental factors may affect the makeup of the gut microbiome.

NutraIngredients is pleased to announce the shortlisted finalists for the 2020 edition of the NutraIngredients Awards ... with the winners to be announced in the first online awards ceremony next week (May 13th).

Rousselot, the collagen-based ingredients producer, has revealed a new study which it says provides important answers surrounding the bioavailability of collagen peptides and the modifications they undergo during digestion.

French beauty supplement firm D+ For Care has launched a mouth spray to aid sleep and has a flurry of holistic wellbeing innovation primed for 2020 â the year nutricosmetics could really take off, its founder says.

A recent study conducted by researchers at Tufts University suggests that consuming 1.5 ounces of almonds per day, compared to no almond consumption, may help reduce CVD risk factors such as elevated LDL cholesterol levels, and as a result, reduce an individual's healthcare costs associated with treating such conditions.

Leaders from around the world gathered at the United Nations General Assembly in New York on 23 September for the first-ever United Nations High-Level Meeting (UNHLM) on Universal Health Coverage (UHC): Moving Together to Build a Healthier World.

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.

APEC officials announced this year’s winners for the annual APEC Business Efficiency and Success Target Awards, or BEST Awards - a collection of some of the best women-led businesses in the Asia-Pacific region.

Policies impacting women’s economic advancement have improved in some areas, but more reforms are needed to enable women to fully thrive, reports the newly updated APEC Women and the Economy Dashboard 2019.

APEC member economies launched the APEC Women in STEM Principles and Actions, a set of suggested principles and actions for encouraging women’s participation in the fields of science, technology, engineering, and mathematics, commonly referred to as STEM.

Ministers address developments in the global economy and take action to safeguard the region’s growth.

President Sebastián Piñera, Chair of APEC Chile 2019, announced that APEC Leaders’ Week will not be held in Chile this year.

Structural reforms can counter slower economic growth in the Asia-Pacific region, says a new report by the APEC Policy Support Unit.

Media Registration is Open for the APEC Informal Senior Officials’ Meeting

Malaysia, incoming host of APEC, will rally the forum to ensure that the ‘”benefits from trade, investment, and economic cooperation are felt and enjoyed by our people,” said Prime Minister Dr Mahathir Mohamad as he launched APEC Malaysia 2020.

Broaden opportunities for people and ensure more inclusive growth across the Asia-Pacific, urged the 2020 Chair of APEC Senior Officials, host of the Asia-Pacific Economic Cooperation in 2020.

Stronger cooperation is essential for APEC as economies address inequality, environmental health, and the digital economy – the region’s critical challenges – said the APEC Secretariat’s Executive Director Dr Rebecca Sta Maria.

Media registration is open for the First APEC Senior Officials’ Meeting (SOM1) and related meetings in Putrajaya, Malaysia from 3 February to 22 February 2020.

Business leaders from around the Asia-Pacific met in Sydney last week to discuss the year ahead

Enable trade and investments to generate concrete outcomes for the people.

The challenge: Innovative mobile apps and platforms that empower the aging society

“I would like to express our appreciation to APEC member economies that put their faith in Malaysia’s leadership and made it a point to participate.”

Trade Ministers agree to work together towards a healthy, resilient and inclusive Asia-Pacific community.

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

From : Communities>>Regulatory Open Forum
Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little. ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs ------------------------------

From : Communities>>Regulatory Open Forum
Hello Jose, To my knowledge, the change of O/O does not trigger a notification that needs to be confirmed, nor does it trigger a review of enforcement history.  The change of ownership and O/O is merely an administrative update that gives FDA both current information and a history of changes.  Of course, if there are known red flags with any of the involved organizations, changes can be scrutinized. Regards, James ------------------------------ James Bonds J.D. Director Regulatory Affairs Atlanta [More]