Key Takeaways The Federal Trade Commission (FTC) has continued its scrutiny of Orange Book listings for device patents, signaling bipartisan concern over potential anti-competitive practices....more
7/14/2025
/ Antitrust Provisions ,
Competition ,
Enforcement Actions ,
FDA Approval ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs
On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment...more
In early July 2018, the United States Food and Drug Administration (FDA) issued a final guidance document titled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA – Guidance for Industry." A...more
8/9/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
New Amendments ,
New Guidance ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements