From the News Desk
It is only March but so far 2012 has been busy! This week CMS unveiled an overhauled Medicare billing statement to allow consumers to detect fraudulent charges more easily. Also this week: The FDA...
View ArticleAdult Stem Cell Treatments: Cosmetic or Drug?
A recent article in Scientific American described the use of stem cells in cosmetic procedures and resulting injury to a patient. Although the Food and Drug Administration (FDA) has approved only one...
View ArticleThe Tattoo Epidemic: What Are The Health Risks?
It seems that everywhere you look today you see people with tattoos. Tattoos, of course, are nothing new, they have been around for thousands of years. In recent times we have predominately seen them...
View ArticleTemporary Tattoos (Including Decal-Type) Are Not Risk Free
On January 23, 2013, in The Tattoo Epidemic: What Are The Health Risks?, we discussed FDA and local government regulation of tattooing, the health risks associated with tattoos, and provided Centers...
View ArticleFDA Launches Advisory Committee Nomination Portal
The FDA announced an online portal on its website for people who wish to submit nominations for membership to any of the FDA’s 33 advisory committees. The portal makes paper nominations unnecessary and...
View Article2015 FDA Budget Request Supports 5-Year Strategic Plan
In April 2011, FDA published a five-year strategic plan, entitled “Strategic Priorities 2011 – 2015.” In that plan, FDA set forth five modernization priorities for the agency. The plan also committed...
View ArticleL’Oréal Skincare Deception Charges Lead to FTC Settlement
The cosmetic giant, L’Oréal USA, Inc., has agreed to settle Federal Trade Commission (FTC) charges that it deceptively advertised two of its skincare products by making false and unsubstantiated claims...
View ArticleStimulating Shape-Wear: Caffeinated Undergarment Weight-Loss Claims Banned
Two manufacturers of caffeine-infused shape-wear for women entered into a settlement agreement with the Federal Trade Commission (FTC) based on charges that the manufacturers made false and...
View ArticleFDA Commissioner Stepping Down After 6 Controversial Years
Dr. Margaret Hamburg, the FDA’s leader for the last six years, announced that she will be stepping down in March 2015. The FDA’s chief scientist, Stephen Ostroff, will become acting commissioner while...
View ArticleBipartisan bill would strengthen FDA’s oversight of cosmetics
The Personal Care Products Safety Act (S. 1014), a new bill sponsored by Senators Dianne Feinstein (D-Cal) and Susan Collins (R-Me), seeks to protect consumers and streamline compliance in the...
View ArticleFDA’s sunblock would ban tanning beds for minors
Addressing health concerns related to indoor tanning beds, the FDA is issuing two proposals that would restrict minors from using indoor tanning beds, regulated as sunlamp products, and require adults...
View ArticleJ&J gets hit with $72M verdict over link between Talc powder and cancer
Litigation alleging that Johnson & Johnson Talc-based powder caused a woman to develop ovarian cancer led to a $72 million verdict against the manufacturer on February 22, 2016. The Missouri...
View ArticleSecond Missouri jury hits J&J with $55M verdict after linking talc to ovarian...
Another Missouri jury awarded $55 million to a woman who sued the company over allegations that she developed ovarian cancer after decades of using talc body powder for feminine hygiene. The verdict...
View ArticleThe Empire State woos pharma, biotech industries
The 21st Century Cures Act (Cures Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016. The Cures Act contains...
View ArticleFDA considers establishing a new ‘Office of Patient Affairs’
The FDA announced that it is establishing a public docket to solicit public input on ongoing efforts to enhance mechanisms for patient engagement at the agency. In addition, to achieve a more...
View ArticleCosmetic drug companies scarred by misbranding
A district court enjoined two individuals and two New Jersey drug companies from distributing unapproved injectable skin whitening drugs. In addition to preventing Flawless Beauty LLC and RDG Imports...
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