Despite the approval given by the government, the insurers can refuse to cover a given device. This was emphasized by the case of Linx, a new medical implant for treatment of severe acid reflux. The device was approved by FDA about 3 years ago and is reimbursed by the Center for Medicaid and Medicare Services … Read more
FDA has proposed some amendments in the existing regulations on over-the-counter drugs and fixed-combination prescription. According to the current regulations, it is the responsibility of the sponsor to make sure that in a fixed combination drug, each of the ingredients should make some contribution towards the claimed effects of the product. The proposed regulation would simplify the … Read more
n an article published this week in Nature Drug Discovery, FDA senior officials reported that of the cancer drugs that failed to gain market approval in the last decade, about one-third were rejected by FDA due to defects in the clinical trial design, while the rest were unsuccessful because the drug failed to show FDA-acceptable efficacy … Read more
On May 18th, FDA issued a draft guidance on Adaptive Design for Medical Device Clinical Studies. This is the first time FDA formally endorsed the use of use of adaptive clinical trial design for medical devices. This guidance follows a previous guidance for use of adaptive clinical trials for testing drugs and biologics released more than 5 years ago. Together … Read more
