Hyman, Phelps, & McNamara

Feeling The Heat (Or Cold) – New Draft Guidance Addresses Requirements For Devices That Produce Thermal Effects

Surely You Must Be Kidding, PTO?!? "No, And Don't Call Me Shirley!" – The Seemingly Slapstick (But Yet Unfunny) World Of Recent Patent Term Extension Decisions (PART 3 . . . And PART 3½)

Drugs Companies Clap Back At Congress…Then Get Sued

Bad Labs! Bad Labs? Whatcha Gonna Do?

FDA Grants A Registration Fee Waiver For Very Small, Broke Device Manufacturers

15 Years Strong: Rare Disease Week's Remarkable Journey Of Support

How To Run DMC? It's Tricky – FDA's New Draft Guidance Provides Updated Recommendations On How To Best Use Data Monitoring Committees In Clinical Trials

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available To FDA Law Blog Readers

Traditional Meat Industry's Beef With Alternative Protein Continues With The FAIR On Labels Act

AstraZeneca's Challenge To Price Negotiation Fails In Federal District Court