Agency IQ

OCTOBER 6, 2023

If a drug was previously approved for cancer, but is now approved for a cardiology condition, it would not be considered novel. The FDA also refers to novel products as “New Molecular Entities,” or NMEs. Data on these novel approvals is published throughout the year by both CDER and CBER. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Drugs 52

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. supplemental oxygen, mechanical ventilation).

FDA 40

FDA Clinical Trials Trials Vaccine 40

Agency IQ

JUNE 16, 2023

The proposed rule will identify certain bulk drug substances that FDA has considered and is proposing to place on the 503A Bulks List and certain bulk drug substances that FDA has considered and is proposing not to include on the 503A Bulks List. fit in this definition.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

January 2024 Amendments to Patent Term Restoration (Proposed Rule) FDA is proposing to amend its Patent Term Restoration regulations to identify the effective date of approval for scheduled drugs, to define when the 60-day period referred to in 35 U.S.C. fit in this definition.

FDA 40

FDA Science Regulations Production 40