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January 16, 2018
FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.
The US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.
The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.
The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.
January 11, 2018
The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.
The European Commission has approved AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
January 10, 2018
Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?
January 05, 2018
FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.
FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.
January 03, 2018
The agency published draft guidance on good practices for submitting abbreviated new drug applications.