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Highlights of USFDA April – May

Highlights of USFDA April – May

FDA authorizes use of new device to treat esophageal birth defect in babies – 12 May 2017


USFDA has authorized the use of Flourish Pediatric Esophageal Atresia Anastomosis which is a first of its kind medical device to infant up to one year old for a birth defect that causes a gap in their oesophagus, called oesophageal atresia.

According to FDA there is 1 in every 2500 babies which is born with oesophageal atresia. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the oesophagus to the stomach. Trachoeoesophageal fistula is also associated with oesophageal atresia that happens in babies which also needs to repair by performing surgery. Having this condition can cause food particle to go into airways.

This device can help these babies to get their condition right. It uses magnet to pull the upper and lower oesophagus together, closing the gap and allowing food to enter the stomach. It is not for use in infants who also have a tracheoesophageal fistula, an abnormal connection between the oesophagus and the windpipe (trachea).

FDA has approved the safety and efficacy and probable benefits of Flourish device. The device is also contraindicated in infants who have an existing tracheoesophageal fistula or who have oesophageal segments that are more than 4 centimeters apart.


FDA takes action against 14 companies for selling illegal cancer treatments – 25 April, 2017


USFDA addressed warning letters to 14 US based companies, which were selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. The product which were marketed and sold in stores and website as well as social media platform. FDA’s regulatory affairs Douglas W. Stearn said that “Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment”. These 14 companies violated the drug and cosmetic act and sold the product which claim to treat cancer. The illegally sold products cited in the warning letters posted included a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas and diagnostics (such as thermography devices).

These marketed products which were used illegally by human or pets. Companies sold this fraudulent product under the claims of preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims.

FDA has requested the 14 companies to correct their violations; if they fail to correct the violation that may result in legal action, including product seizure, injunction and/or criminal prosecution. FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.


FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions – 06 April, 2017


USFDA has authorized for the marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These 10 tests are first that which are approved by FDA and these are direct-to-consumer (DTC). These tests also provide information on an individual’s genetic predisposition to certain medical diseases or conditions. By doing these test they provide genetic risk information to consumers, but it can’t determine person’s overall risk of developing a disease or condition. In addition to the presence of certain genetic variants, there are many factors that contribute to the development of a health condition, including environmental and lifestyle factors. The 23andMe GHR tests work by isolating DNA from a saliva sample, which is then tested for more than 500,000 genetic variants. These DNA test can detect the following diseases or conditions:

  • Parkinson’s disease, a nervous system disorder impacting movement;
  • Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills;
  • Celiac disease, a disorder resulting in the inability to digest gluten;
  • Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease;
  • Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements;
  • Factor XI deficiency, a blood clotting disorder;
  • Gaucher disease type 1, an organ and tissue disorder;
  • Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition;
  • Hereditary hemochromatosis, an iron overload disorder; and
  • Hereditary thrombophilia, a blood clot disorder.

These tests can help in early diagnostics of the conditions so that lives of people can be saved or prolonged.


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