Scientists at Abbott discover first new HIV strain since 2000: ‘We’re working to stay a step...
The newly discovered strain, called HIV-1 Group M, subtype L, was first collected in the 1980s in the Democratic Republic of the Congo, but there were only two samples that could be examined via gene sequencing.
How DSJCPA Can Help With Grant Authorization For Non Profits
DSJCPA can help with all of your non profit accounting needs. Visit us today if you need assistance with grant authorization, not for profit accounting or advice.
FDA Determines Functional Equivalence for DuPont Products
The FDA has recently determined that DuPont’s new (Transition) Tyvek® products are functionally equivalent to existing (Legacy) Tyvek® products. What does this mean for medical device manufacturers?
FDA Grants Priority Review of 10 mg XARELTO to Reduce VTE Risk
Janssen announced the FDA accepted for Priority Review a sNDA for XARELTO to include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy.
FDA Gives OK to First New Flu Drug in 20 Years
The drug's approval was based on two clinical trials of more than 1,800 patients who took either Xofluza, a placebo or another antiviral flu treatment within 48 hours of experiencing flu symptoms.
FDA Issues New Seafood Advice For Moms-To-Be. Not Everyone Is Thrilled
Concerns about mercury contamination have led many pregnant women to under-consume seafood. So the FDA issued a new chart explaining what to eat and what to avoid. But critics say it muddles matters.
How will the FDA regulate 3D printing?
Pharmaceutical and medical device manufacturers increasingly are using 3D printing (aka “additive manufacturing”) to manufacture their drugs and…
How Abbott Is Gaining New ‘FlexAbility’ in Arrhythmia Market
Qmed (formerly Medical Device Link) is the world's first completely prequalified supplier directory and news source for medical device OEMs. Find medical device suppliers and IVD suppliers who are FDA-registered, ISO 13485- and ISO 9001-certified. Qmed is also the home of Medical Product Manufacturing News and the most relevant breaking news for the medical device industry.
Lessons Learned From Year One Of The FDA's Expedited Access Pathway
During the first year of the program, FDA officials report that the agency has made 29 decisions on requests for EAP designation: 17 have been accepted into the program, and 12 have been denied. These decisions were typically made in 30 days.
Waterway Cleanup Grants, Deadline Feb. 20
. The Michigan Department of Environmental Quality (MDEQ) and Great Lakes Commission today announced the availability of $25,000 for small grants to support local efforts to clean up Michigan river…
FDA approves 20 minute take-home HIV test
The FDA has approved an over-the-counter HIV test that uses a mouth swab to give results in 20 minutes.
How to Integrate Human Factors in the Development Process for FDA Compliance
Free Webinar Recording and Frequently Asked Human Factors Questions Learn how to design a Human Factors plan using a simple medical device that could be used to satisfy IEC 62366 and other FDA guidance on product development process requirements. From the marketing requirements to the product release, see which Human Factors tasks are integrated and how into the various product development stages Webinar was originally aired…
What is Return Merchandise Authorization
Return Merchandise Authorization or RMA is a complex process that needs careful evaluation. Learn about RMA and some common policy attributes.
A Brief Guide to FDA Draft Guidance for Foreign Clinical Trial Data in Medical Device Approvals
With the newly issued draft guidance, the FDA details special considerations and evidence requirements for foreign clinical study data.
What to Watch: Abbott breathes new life into bathroom bill
AUSTIN, Texas (AP) -- For months, Gov. Greg Abbott stayed silent and Texas' bathroom bill languished in the Legislature amid mounting criticism from LGBT activists and business groups.Now Abbott's all-in, becoming the nation's first governor to fully embra
How Abbott's New Continuous Glucose Monitor Can Change The Company
New data released by Abbott on the FreeStyle Libre Continuous Glucose Monitor shows it lowers blood sugar levels across the board by nearly a full percentage po
New FDA Sunscreen Rules Explained
www.clderm.com Dr. William Groff was on Fox 5 San Diego in the morning reviewing the new FDA sunscreen rules. He discusses sunscreen effectiveness and...
"Abbott and Costello: The Complete Universal Pictures Collection" and Other Amazing New Releases
An incredible Abbott & Costello Blu-ray set leads off another stellar week of new releases!
Why Every Woman Needs To Have a Gluten Antibody Test BEFORE Pregnancy
Current research indicates a clear relationship between a mother's sensitivity to gluten and the mental health of her child.
What liquor stores think about new alcohol delivery bill signed by Gov. Abbott
People will soon be able to enjoy happy hour from the comfort of their own living room as Gov. Greg Abbott signed a bill that allows businesses with mixed beverage permits to deliver alcoholic drinks straight to your doorstep. David Hernandez owns Holiday Wine & Liquor in McAllen, which has been around since 1982. Although there is already a lot of competition out there, Hernandez doesn't think the bill will affect sales greatly.