FDA News

SmartLipo365 initiates voluntary nationwide recall due to undeclared ingredients

June 4, 2015
SmartLipo365 issued a voluntary recall of Smart Lipo (800, 900, 950 mg) capsules as a result of undeclared sibutramine, desmethylsibutramine and…

Health Law News From Arnold & Porter Kaye Scholer

Proposed legislation may offer some relief from the threat of recovery audit contractors

June 4, 2015
From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh…

Health Law News From Arnold & Porter Kaye Scholer

Are you in an Alternative Payment Model? Why it matters

May 4, 2015
From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh…

Breaking News

House passes bill to repeal sustainable growth rate

March 26, 2015
By a vote of 392 to 37, the U.S. House of Representatives passed a bipartisan bill today that repeals the sustainable growth rate, a key factor in…

FDA News

FDA reminds consumers to be wary of inappropriate cosmetic claims

March 25, 2015
In a recent Consumer Health Information update, the FDA reminded consumers that cosmetics that claim to mitigate a disease or a condition, such as…

FDA News

FDA issues warning letter to Strivectin

March 19, 2015
The FDA has issued a letter to Strivectin regarding two products that were found to be in violation of section 201(g)(1)(C) of the Federal Food, Drug…

Medical Board of Australia proposes draft guidelines for cosmetic medical surgical procedures

March 18, 2015
As part of a new draft of guidelines pertaining to cosmetic medical and surgical procedures, the Medical Board of Australia has proposed a 7-day…

In the Journals

Postop complication rates vary at outpatient plastic surgery facilities in California

March 13, 2015
In a retrospective review of complication rates at outpatient plastic surgery centers in California, researchers discovered significant variability…

Recent FDA updates in aesthetics

March 3, 2015
The FDA has taken a number steps during the first quarter of 2015 to improve safety and effectiveness within the aesthetics market. The approval of a…

FDA News

FDA advisory committee recommends Radiesse for hand augmentation

February 27, 2015
The General and Plastic Surgery Devices Panel of the FDA’s Medical Devices Advisory Committee has voted in favor of recommending expanding the…

FDA NewsFDA approvalsDrug/Device Pipeline

Allergan granted FDA approval for Natrelle Inspira gel-filled implants

February 27, 2015
Allergan announced that the FDA has given market approval for its Natrelle Inspira round gel-filled, smooth breast implants. “In the past 2…

FDA News

FDA reports progress of clinical trial demographic information analysis

February 23, 2015
In a recent blog post on the FDA website, Barbara D. Buch, MD, chair of the Section 907 steering committee and associate director for medicine at…

FDA News

FDA provides update on microbiological safety, cosmetics

February 12, 2015
Although injuries from contaminated cosmetics are not common, they can be serious, according to a cosmetic safety update from the FDA. The update…

FDA News

FDA warning letter defines differences between cosmetic, medical devices

January 28, 2015
The FDA posted a statement regarding recent warning letters they have sent out to a number of companies hoping to clarify the differences between…

Actavis, Allergan announce SEC declaration, shareholder meetings on pending acquisition

January 27, 2015
Actavis and Allergan announced that the U.S. Securities and Exchange Commission has declared Actavis’ registration statement on Form S-4 with…

Industry News

FDA Commissioner responds to Call to Action for skin cancer prevention

July 29, 2014
U.S. Food and Drug Administration Commissioner Margaret A. Hamburg has released a statement regarding the Surgeon General’s Call to Action to…

Industry News

Delaware bans minors from indoor tanning

July 29, 2014
Delaware Gov. Jack Markell has signed a bill into law prohibiting individuals under the age of 18 from indoor tanning. The law, which also mandates…

Industry News

Hawaii becomes 10th state to bar minors from indoor tanning

July 3, 2014
Hawaii Gov. Neil Abercrombie signed into law a bill that prohibits minors under 18 years from indoor tanning, effective immediately. Hawaii joins…

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