fda Latest News

FDA regulations, distribution channels, product marketing, the U.S. organics market and risk management are among the topics to be discussed at upcoming events in Hanover.

World Leaders to Convene on October 10-12, 2012, Bethesda, MD

This conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic (August 21-23).

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

This conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic (Aug. 21-23).

Hear Diagnostics Perspectives on Personalized Medicine and Companion Tests. This conference is part of the Next Generation Dx Summit: Moving Assays to the Clinic.

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.

American CryoStem Corporation announced the launch of its new adipose tissue and adult stem cell testing services to assist physicians involved in tissue engraftment, regenerative medicine procedures and cellular therapies.

Ensuring Quality through Effective Assessment, Qualification, Auditing, and Communication

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

This seminar will discuss how to comply with FDA's ongoing Part 11 inspection program

This seminar will discuss how FDA did change inspection practices and how to respond to avoid 483s and Warning Letters

Ensuring Audit Readiness and GCP Compliance across Clinical Research Functions

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.

3D Communications considers the A/V component of meeting preparation to be ‘mission critical’ and relies on the Sennheiser Audio Distribution Network (ADN) conferencing system to facilitate audio during its meetings.

Advanced Cancer Therapeutics (ACT) has been granted U.S. Patent 8,088,385 B2 titled “PFKFB3 inhibitor for the treatment of a Proliferative Cancer” by the United States Patent Office.

EMSL Analytical offers quality testing services for Salmonella and other foodborne pathogens

Recently published research from Datamonitor, "Bydureon FDA Approval: Physician Opinion", is now available at Fast Market Research

Vaginal mesh helpline is seeing an alarming increase of women calling with vaginal mesh complications from thru-Out the United States. Complications range from mild to severe. Husbands and family members are calling concerned.

Created specifically to address the continued implementation of key provisions under the Food Safety Modernization Act, as well as the day-to-day challenges faced by food safety, regulatory and compliance departments across the food industry.

EMSL Analytical always performs a culture-based confirmatory test for Salmonella

GAWDA consultant Thomas L. Badstubner discussed FDA inspection trends.

K2M, Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SANTORINI™ Corpectomy Cage Systems.

The FDA announced a hearing to explore prescription to over-the-counter switch opportunities. Francesco International LLC, a pharmaceutical and healthcare consultancy predicted this change and recently published a breakthrough report on the issue.

ASI’s GenASIs automated scanning and image analysis system for detection and quantifying chromosome 17 and the HER-2/neu gene has been cleared by the United States Food and Drug Administration (FDA) for marketing in the US

The Health and Human Services Department has refused to allow the morning-after pill to be sold to girls under 17 without a prescription, reversing an FDA decision.

FDA Approves Mitosol® for Immediate Production and Use in Glaucoma Surgery

Pira International is pleased to announce that for 2012, their very successful food contact event, Global Food Contact, will be coming to the USA.

Vaginal Mesh Helpline is on the look out for new updated information. There has been a multi district consolidation of three Vaginal mesh Implants in West Virginia. The vaginal Mesh helpline hears from women daily with horror stories

HIT Consultant Founder Fred Pennic talks with GE Healthcare Senior Marketing Manager of Radiology Lawrence White about the Centricity Radiology Mobile Access Application.

Intronix wins US regulatory clearance for its Myoguide device with assistance from Emergo Group

GenASIs Scan & Analysis cleared for FISH Detection and Analysis of chromosomal abnormalities in urine specimens

This seminar will discuss strategies and present examples on what to train, how much to train and how to document effectiveness

This seminar will discuss strategies and present examples on how to transfer analytical methods most efficiently

Vaginal mesh Helpline is seeing an increase in calls from women In Florida With vaginal mesh Complications, specifically the South Florida Dade, Broward Palm beach Area. This includes Miami thru West Palm Beach

It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent

Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR,

SABIC’s Innovative Plastics business today announced that its manufacturing facilities in Campinas, Brazil and Tortuguitas, Argentina, are now certified to produce U.S. Food and Drug Administration (FDA)-compliant and biocompatible resins

Delegates now have the option to choose from 3 moderated breakout discussion groups at this conference that is set for February 21-23, San Francisco, CA (part of CHI's Molecular Med TRI-CON 2012).

Dermaroller ® Warns: FDA does not approve the reuse of Single-Use Only medical micro-needling devices.

Vaginal mesh Helpline listens to women on a Daily basis seeking lawyers who are sensitive to their plight. The biggest complaint is law firms make them feel like a number. The vaginal mesh Helpline is accepting lawyers who meet our criteria.

This seminar will discuss strategies and present examples for qualification of virtual networks and cloud computing

This seminar will discuss how design robustness of analytical methods for easy transfer and to avoid OOS situations

Hundreds of thousands of families affected my defective vaginal mesh surgeries. American Husbands find a new resource to help their wives, families and relationships.

Students are researching ways to improve Salmonella detection in eggs

The FDA is likely to follow a government-mandated report which recommends that nicotine products designed to substitute for cigarette smoking be subjected to such expensive testing that few companies could afford to market them

The Food & Drug Administration is scheduled to release guidelines for the approval of biosimilars by the end of 2011

EMSL Analytical, Inc. offers a variety of consumer products testing, including bisphenol-A analysis

Bootstrap America's Sophia Vander looks at the dangers of genetically engineered foods.