Final, Level 2 guidance released (revised version from guidance issued in July 2022): Failure to Respond to an abbreviated new drug application (ANDA) Complete Response Letter Within the Regulatory Timeframe Guidance for Industry
Provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a complete response letters (CRL), as well as the actions that FDA may take if the applicant fails to respond to that CRL.
Revision 1 to draft guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection
Defines the types of behaviours (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection.
Draft guidance released for public consultation: Content of Human Factors Information in Medical Device Marketing Submissions
The recommendations in this guidance are intended to promote consistency and facilitate efficient review of medical device submissions. Consultation ends 09 March 2023.
Approved drug labelling under Project Renewal
FDA approves updated drug labelling including new indications and dosing regimens for capecitabine tablets (Xeloda). Project Renewal, an Oncology Center of Excellence initiative aimed at updating labelling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date. This is the first drug to receive a labelling update under this pilot program.
First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer
FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
New HIV Drug for Adults with Limited Treatment Options
Sunlenca (lenacapavir), a new type of antiretroviral medication has been approved for adults living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1.
40th biosimilar approval in the US
FDA approved Idacio (adalimumab-aacf), a biosimilar for Humira (adalimumab), marking the 40th biosimilar approval in the U.S. Idacio is a tumor necrosis factor blocker indicated for the treatment of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis and Plaque Psoriasis.
FDA 2021 Year in review
Report from Janet Woodcock, M.D., FDA's Acting Commissioner, highlighting FDA's work in 2021.