Genetic Metabolic Diseases Advisory Committee Roster
Genetic Metabolic Diseases Advisory Committee Roster lists the current members and the current number of vacancies for the committee.
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used…
KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg,…
Development of Non-Opioid Analgesics for Chronic Pain
This draft guidance for industry is intended to assist sponsors in the development of non-opioid analgesics for the treatment of…
FDA Issues New Guidance to Expand Non-Opioid Options for Chronic Pain, Curb Misuse
As part of its broader strategy to address the opioid crisis, the U.S. Food and Drug Administration today issued draft…
FDA Launches Crackdown on Deceptive Drug Advertising
The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein…
Detection of Anabolic Androgenic Steroids and Steroid Esters—Comparing Dried Blood Spots Collection Devices and Urine Samples
DBS (Capitainer-B50 and Tasso-M20) enabled detection of testosterone esters in all participants, whereas urine testing (T/E) missed cases including potential…
Detection of Anabolic Androgenic Steroids and Steroid Esters—Comparing Dried Blood Spots Collection Devices and Urine Samples
DBS (Capitainer-B50 and Tasso-M20) enabled detection of testosterone esters in all participants, whereas urine testing (T/E) missed cases including potential…
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with…
Office of Prescription Drug Promotion (OPDP) Research
The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of…