FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov

Press Announcements > FDA approves first autologous cellularized scaffold for the repair of cartilage defects of the knee - FDA.gov:

"The U.S. Food and Drug Administration today approved Maci (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. Maci is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee."

'via Blog this'


Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Training - FDA cGMP QSR GMP - Courses, classes, workshops, seminars

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers

View the annotated list:  2016 FDA Guidance Documents You Should Know | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"This year FDA again issued several guidance documents that have substantial, positive implications for portfolio productivity and strategy. The following 2016 guidance documents merit careful consideration by every device manufacturer." . . .

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Training Courses - FDA cGMP QSR GMP - Courses, classes, workshops, & seminars

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence

Look into this crystal ball:  Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence:

"First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Training - FDA cGMP QSR GMP classes, courses, workshops, & seminars

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA’s Lax Enforcement Trend Continues - Pharma Marketing Blog

Read article & view chart: Pharma Marketing Blog: FDA’s Lax Enforcement Trend Continues:

"FDA continues to issue fewer and fewer warning and untitled letters. As of today (8 December 2016) FDA has issued only 5 enforcement letters (4 untitled and 1 warning letter) compared to 9 letters in 2015."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

FDA cGMP QSR GMP Training

FDA cGMP QSR GMP Training

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
The Health, Drug, Prescription, and GMP Supersite Gift Store 

What the 21st Century Cures Act is, and who benefits from it - Business Insider

Read the full article: What the 21st Century Cures Act is, and who benefits from it - Business Insider:

"Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There's also money to help states fight the opioid epidemic, and a boost for mental health care."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

GMP Training - FDA cGMP QSR GMP classes, courses, workshops, & seminars

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

Eating a Handful of Nuts May Prevent Major Diseases | TIME

Read the full article: Eating a Handful of Nuts May Prevent Major Diseases | TIME:

"People who ate about about a handful (20g) of any type of nuts—tree nuts, like hazelnuts, walnuts, pecans and almonds, and peanuts, which are legumes—a day had nearly 30% lower heart disease rates compared to people who didn’t eat nuts, a conclusion previous data supported. But they also had a 15% lower risk of cancer and a 22% lower risk of dying prematurely of any cause. People who ate nuts regularly also cut their risk of dying from respiratory illnesses by nearly half, and they reduced their risk of diabetes by nearly 40%."

'via Blog this'

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store