Two Hyman, Phelps attorneys discuss lessons industry should learn from civil and criminal cases against medical device manufacturer ACell.
FDA says ANDAs for products indicated for emergency treatment of known or suspected opioid overdose are eligible for priority review under the HHS pub...
A 7/6 New York Times editorial board opinion piece urges the Trump Administration to curb drug price increases the way Europe does by tying a drugs p...
On the eve a rule was to go into effect to require drug pricing information in direct-to-consumer ads, the Washington, DC federal court rules that HHS...
FDA Review posts the Federal Register notices for the week ending 7/5/2019.
FDA Review posts product approval summaries for the week ending 7/5/2019.
FDA posts a final guidance entitled Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.