HHS backed down from implementing its more controversial provisions in a broad overhaul of its Common Rule, including requiring researchers to obtain written consent before testing a donor’s biospecimens, even…
The HHS secretary recently delivered FDA’s recommendations for reauthorizing user fees covering prescriptions, generic drugs and biosimilars to Congress, before the body begins to craft a legislation package due by…
The FDA has made great strides in conducting international inspections — but still remains detrimentally understaffed, according to the government’s official watchdog, during a time when the agency has begun…
The UK’s price watchdog is backing coverage for Pfizer’s Bosulif at a new discounted price, broadening access to the drug that was previously only available through the now-revamped Cancer Drugs…
AstraZeneca’s lawsuit against the FDA over the exclusivity of one of its drugs is a “transparent” effort to stifle generic competition for the blockbuster anti-cholesterol drug Crestor, the FDA said…
The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an…
Pfizer has pledged to communicate all the risks associated with opioids in future ads under an unusual accord it reached with the city of Chicago. Source: Drug Industry Daily
Source: Drug Industry Daily