The U.S. Food and Drug Administration has issued warning letters to Sientra Inc ...
- The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson & Johnson unit for failing to comply with the post-approval study requirements for their breast implants.
The agency’s letters, dated March 18, highlighted issues in the companies’ post-approval studies, which included evaluating the long-term performance and safety of the implants, used for breast augmentation and reconstruction procedures. Sientra had reported poor patient follow-up rate of 61 percent for the post-approval study of its Silicone Gel Breast Implants, which required the company to evaluate the study subjects annually for 10 years, according to the FDA letter.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
Kind bars wants the FDA to change how it regulates food labelsKind, the maker of the popular nut bars, filed a petition Wednesday asking the FDA to change how it regulates claims on food labels.
Lire la suite »
U.S. proposes stricter curbs on e-cigarette salesThe U.S. Food and Drug Administration (FDA) on Wednesday released formal plans t...
Lire la suite »
FDA tightens restrictions on e-cigarette sales and fruity flavors to stem teen vapingFDA tightens restrictions on e-cigarette sales and fruity flavors to stem teen vaping.
Lire la suite »
FDA puts partial hold on clinical trials of AbbVie's cancer drugAbbVie Inc said on Tuesday the U.S. Food and Drug Administration placed a partia...
Lire la suite »
FDA considers yanking nicotine vaping pods off the marketU.S. Food and Drug Administration Commissioner Scott Gottlieb said Tuesday that his agency may need to pull pod-based nicotine products off the market as it fights a surge in teen vaping.
Lire la suite »
FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vapingOutgoing FDA chief Scott Gottlieb released the agency's much-anticipated draft rules restricting e-cigarette sales, tightening sales and eventually remove from the market many of the fruity flavors he's blamed on fueling an 'epidemic' of teen use.
Lire la suite »
FDA Sets Limits on Retail Sales of Flavored E-CigarettesConvenience stores and gas stations will effectively be banned from selling most flavored e-cigarettes under restrictions issued by the Food and Drug Administration.
Lire la suite »
FDA rolls out vaping policy to make it harder for minors to buy flavored productsThe Food and Drug Administration, responding to the surge in underage vaping, on Wednesday issued a much-anticipated policy designed to make it harder for young people to acquire many types of e-cigarettes.
Lire la suite »