The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.
Following Walgreens' decision to acquire the rest of the Alliance Boots business — and to keep its headquarters based in the greater Chicago area — Sen. Dick Durbin, D-Ill., weighs in on the decision in a brief video.
Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.
New York City's Department of Health and Mental Hygiene said a man who was tested for Ebola at Mount Sinai Hospital is "unlikely" to have the virus. The patient was admitted to the hospital early Monday with a fever and gastrointestinal problems. He recently visited a West African country where Ebola was reported, according to the Washington Post.
The Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis and/or in patients with emphysema that are experiencing airflow obstruction, the agency announced.
Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.
The National Association of Specialty Pharmacy and the Specialty Pharmacy Association of America announced the merger of the two organizations, creating the largest professional and trade association focused on the unique needs in specialty pharmacy.