Welcome to issue two of Foley’s Manufacturing MarketTrends newsletter, which highlights key trends with the potential to make 2019 a year of change for manufacturers. In this issue, we will explore collaboration between the...more
7/12/2019
/ Artificial Intelligence ,
Big Data ,
Biotechnology ,
Blockchain ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Machine Learning ,
Manufacturers ,
Regulatory Agenda ,
Supply Chain ,
USDA
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more
3/21/2017
/ 21st Century Cures Act ,
Draft Guidance ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Human Genes ,
Life Sciences ,
Medical Research ,
Public Comment ,
Public Health Service Act ,
Stem cells
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
7/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
CAFC ,
Commercial Marketing ,
Exclusivity ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health Service Act ,
Rulemaking Process
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more
2/12/2016
/ Advisory Committee ,
Amgen ,
Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Johnson & Johnson ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz