fda Latest News

--- Temperature@lert, a leader in environmental condition monitoring, has announced major client win in the natural foods and beverages industry.—

Examines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k)...

As the FDA is poised to issue new rules governing e-cigarettes, a new study has found some 22 potentially dangerous chemical elements in the vapor given off or inhaled - Other studies also find risks, and major health organizations warn...

After 14 years as a pilot for a corporate airline, the FDA grounded A.J. Catone when he was diagnosed with a rare disease, neuroendocrine tumor cancer which became infamous when Steve Jobs of Apple succumbed to it in 2011.

GPMG, a medical device consulting firm, unveiled a new product to help Initial Importers of medical devices comply with FDA regulations. The design of the system allows for immediate implementation and fits varying organizational structures.

Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication

Take this opportunity to benchmark your internal protocols against those of you peers at Allergan, AstraZeneca, Bayer, BioMarin Pharmaceuticals Inc., Bristol Myers, GlaxoSmithKline, Grünenthal, J&J, Merck, Inc., Pfizer, Roche, Teva and more

Alere Inc. received confirmation that the U.S. Food and Drug Administration (FDA) has cleared the TECHLAB® SHIGA TOXIN QUIK CHEK test for the U.S. market.

This web-seminar will discuss requirements and strategies for cost-effective qualification of IT Infrastructure and Network in FDA regulated and international environments. Attendes will receive 10+ best practice guides for easy implementation.

This web seminar will discuss how to how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies. Attendes will receive 10+ best practice guides for easy implementation.

On October 10th, ACI will kickoff this season’s Hatch-Waxman series with the 13th edition of Maximizing Pharmaceutical Patent Life Cycles at the Downtown Marriott Hotel in New York City.

ACI introduces its Guide to Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.

Learn about FDA QSR, cGMP, GMP. How FDA guidelines apply to medical device manufacturing and product quality. Identify gaps in the quality system. Immediately apply learnings in your workplace. Hands on, live instructor training in Miami / Doral.

This latest book released by Business Horizons represents the latest global quality standards that pharmaceutical manufacturers are striving for today, in order to achieve compliance in today's stringent norms by regulatory agencies.

HANNOVER, Germany, June 15 , 2012 — Tim Forrest Consulting (St. Simons Island, Georgia), a recognized food industry leader, presented on FDA regulations, US distribution channels, and product marketing to 58 companies on June 14 at Food Forum USA.

Hoag Memorial Hospital Presbyterian Doctor publishes article alerting people with MS about serious negative effects of Liberation Therapy

The ingredient DMAA/Geranium is one of the most controversial ever to find its way into the dietary supplement industry. However, sports nutrition company All American EFX is seeing record sales despite not ever using it in their products.

The state’s stem cell agency, CIRM (California Institute for Regenerative Medicine) is committing up to $30 million to a Strategic Partnership Awards Initiative to attract industry engagement and investment in CIRM-funded stem cell research.

This seminar will discuss how to control changes of hardware, firmware, software and documentation of computer systems and netorks

FDA Regulatory Standards, Good Manufacturing Practice (GMP), and Operational Excellence are the focus of Lean Compliance Partners, LLC. The use of Lean, ISO, quality management, training and development helps clients manage risk and reduce cost.

The health risks of consuming too much caffeine, especially for vulnerable populations, and the easy availability of these products should cause the U.S. Food and Drug Administration to be especially vigilant and proactive in regulating caffeine.

Ennis & Ennis, P.A. reports that the FDA is warning of the dangers of DMAA and is working to ensure that any dietary supplements containing the stimulant, dimethylamylamine (DMAA) will no longer be distributed or sold in the U.S. marketplace.

Author and Primal lifestyle expert, Gary Collins, agrees with FDA’s latest consumer warning about DMAA-containing supplements and offers a safe, natural alternative for a pre-workout boost.

--- Temperature@lert, a leader in environmental condition monitoring, has announced major client win in the natural foods and beverages industry.—

Experts Say The Drug May Help Curb Some Pregnancy Complications

Major e cigarette manufacturing companies are doing everything possible to keep on promoting e cigs as a recreational device and not a smoking cessation device.

Examines Additional Considerations for Sharps Prevention Features and Submissions for a Modified Medical Device with Existing 510(k)...

As the FDA is poised to issue new rules governing e-cigarettes, a new study has found some 22 potentially dangerous chemical elements in the vapor given off or inhaled - Other studies also find risks, and major health organizations warn...

A sugar-free bakery that also focuses on other healthy alternatives for baked goods and desserts has been found to be lying about the ingredients and contents of some of their delectable treats.

Mumbai (http://www.rablonhealthcare.com/): Mumbai has gained enough popularity as being the popular industrial city, moreover, being the initiative city that provides employment to so many people.

Rablon healthcare Pvt Ltd this company made its presence in the pharmaceutical market in the year 2012 & from then has been employing effective techniques to mark a positive impression in the minds of the people.

After 14 years as a pilot for a corporate airline, the FDA grounded A.J. Catone when he was diagnosed with a rare disease, neuroendocrine tumor cancer which became infamous when Steve Jobs of Apple succumbed to it in 2011.

GPMG, a medical device consulting firm, unveiled a new product to help Initial Importers of medical devices comply with FDA regulations. The design of the system allows for immediate implementation and fits varying organizational structures.

Interview with Mary Elicone, Associate Director, Global Regulatory Affairs Labeling at Sanofi US

Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication

The NEW FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Safe Use reveals that more than $30 billion of prescription drug sales could convert to OTC in the next few years.

2012 was to be a busy and significant year for the US Food Safety Modernisation Act. The last 12 months have seen the majority of its programmes drafted, but because of government review procedures no major programme has been implemented yet.

World's First FDA Cleared ALK Automated Gene Scanner for Lung Cancer Therapy-Selection Available from ASI Targeting the Right Treatment for the Right Patient in ALK Therapy Selection for Non-Small-Cell Lung Cancer

The NEW FDA-Driven Rx-to-OTC Switch Initiative: The Expansion of Conditions of Safe Use reveals that more than $30 billion of prescription drug sales could convert to OTC in the next few years.

The Food and Drug Administration (FDA) issued a Safety Communication on January 17, 2013 to the medical community and patients who are considering or have received a metal-on-metal hip implant, warning of the unique risks of all-metal implants.

Speed Sleep offers an innovative, drug-free means of improving the quality and quantity of your sleep.

A recent petition was started to prevent the FDA form banning electronic cigarettes. With 10,000 votes, the petition only needs a few thousand more votes.

FDA alerts more than 350 medical practices nationwide that they may have purchased unapproved Botox. Are these practices risking your health to save a few bucks?

Take this opportunity to benchmark your internal protocols against those of you peers at Allergan, AstraZeneca, Bayer, BioMarin Pharmaceuticals Inc., Bristol Myers, GlaxoSmithKline, Grünenthal, J&J, Merck, Inc., Pfizer, Roche, Teva and more

Two time Oscar winner Barbara Kopple (Harlan Country USA, American Dream) explores in her new documentary Fight to Live the absolute powers of the FDA over our rights and access to therapies needed to fight deadly diseases.

Alere Inc. received confirmation that the U.S. Food and Drug Administration (FDA) has cleared the TECHLAB® SHIGA TOXIN QUIK CHEK test for the U.S. market.

The FDA released a stop selling and stop using order yesterday to any sellers, distributors, or users of Zi Xiu Tang bee pollen capsules.

Daniel Hines, publisher of TodaysSeniorsNetwork.com, warns of unintended consequences of FDA misidentifying safe internet pharmacies, urges extension of reciprocity to personal importation of safe, affordable prescription medicines.

This 90-minute training on the FDA system based inspection technique will focus on the responsibilities of the laboratory within the systems based inspection approach and will help the personnel in the quality control laboratory.

Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices.

Pending Changes To FDA Food Facility Registrations and Reregistrations

This web-seminar will discuss requirements and strategies for cost-effective qualification of IT Infrastructure and Network in FDA regulated and international environments. Attendes will receive 10+ best practice guides for easy implementation.

This web seminar will discuss how to how to combine the cost benefits of modern IT Cloud computing with requirements of FDA and equivalent interntional agencies. Attendes will receive 10+ best practice guides for easy implementation.

This web-seminar will discuss how to design, prepare, conduct and document method validation exaperiments for Good Laboratory Practice and Good Clinical Practice studies. Attendes will receive 10+ best practice guides for easy implementation.

This web-seminar will discuss how to use electronic and digital signatures for FDA and international compliance.

On October 10th, ACI will kickoff this season’s Hatch-Waxman series with the 13th edition of Maximizing Pharmaceutical Patent Life Cycles at the Downtown Marriott Hotel in New York City.

ACI introduces its Guide to Orphan Drugs and Rare Diseases: Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.

This seminar will discuss how to apply USP chapter for all laboratory equipment and systems

The U.S. Food and Drug Administration (FDA) has created a database from 40 clinical studies to assess gender differences in the efficacy of antiretroviral treatments. The results of the study are presented in an article in AIDS Patient Care and STDs.

Ganeden Biotech Receives “No Objection” Letter from the FDA; GanedenBC30 is First Bacillus Strain to Receive GRAS Status

With representation by Susan Kirshner, Jack Ragheb, Amy Rosenberg, and Daniela Verthelyi.

This seminar will discuss the new risk based approach and attendees will get get real world case studies for testing

EMSL Analytical provides testing for BPA in consumer products, in food samples, and in the air for workplace exposure assessments.

Learn about FDA QSR, cGMP, GMP. How FDA guidelines apply to medical device manufacturing and product quality. Identify gaps in the quality system. Immediately apply learnings in your workplace. Hands on, live instructor training in Miami / Doral.

ACI’s FDA & USDA Compliance Boot Camp will engage attendees in a deep-dive, two-day examination of food law fundamentals, including an intense exploration of regulations governing food, including meat, poultry and egg products, as well as beverages

FDA highlights the vital role of CME in educating physicians and improving patient outcomes.

This latest book released by Business Horizons represents the latest global quality standards that pharmaceutical manufacturers are striving for today, in order to achieve compliance in today's stringent norms by regulatory agencies.

ACI is pleased to announce its upcoming, FDA & USDA Compliance Boot Camp, scheduled to take place on October 3-4, 2012 at the Millennium Knickerbocker in Chicago, IL.

International Probiotics Association looking forward to working with FDA to develop proper guidance necessary to deliver safe and effective supplements to consumers

HANNOVER, Germany, June 15 , 2012 — Tim Forrest Consulting (St. Simons Island, Georgia), a recognized food industry leader, presented on FDA regulations, US distribution channels, and product marketing to 58 companies on June 14 at Food Forum USA.