Regulatory Updates
Aug 30, 2026•1 min read
Korea advances legal framework for medical cannabis to aid rare disease patients
A policy forum at the National Assembly discussed establishing a legal basis for introducing and producing cannabis‑derived medicines to ensure stable supply for rare and intractable disease patients.
Regulatory Updates
Aug 30, 2026•1 min read
MHRA Safety Roundup – Latest Advice for Medicines and Devices
A brief summary of the MHRA’s latest safety advice for medicines and medical device users.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Recall Issued Due to Lack of Assurance of Sterility
The FDA has initiated a recall because the product lacks assurance of sterility, raising safety concerns.
Regulatory Updates
Aug 30, 2026•1 min read
Korean Lawmaker Proposes AI Use in Local Tax Delinquency Management
Lawyer Seo Young-seok (Democratic Party) introduced a bill to amend the Local Tax Basic Act, allowing AI and intelligent IT for proactive tax delinquency management in Korea.
Regulatory Updates
Aug 30, 2026•1 min read
Korea Sets 0.018% Basic Burden Rate for 2026 Drug Adverse Reaction Compensation Fund
The Korea Pharmaceutical Safety Management Agency announced a 0.018% basic burden rate for the 2026 drug adverse reaction compensation fund, applicable to the Jan and July assessments.
Regulatory Updates
Aug 30, 2026•1 min read
FDA approves ANDA 078079 for ciclopirox 8% topical solution
FDA issued an approval letter on Sep 25, 2007 for Teva Pharms' ANDA 078079 covering a discontinued ciclopirox 8% topical solution.
Regulatory Updates
Aug 30, 2026•1 min read
Abiomed Voluntary Recall of Automated Impella Controller in Canada Over Purge Flag Issues
Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag failures that can cause device troubleshooting and temporary hemodynamic support gaps.
Regulatory Updates
Aug 30, 2026•1 min read
Abiomed Voluntary Recall of Automated Impella Controllers in Canada Over Purge Flag Issues
Abiomed has issued a voluntary recall of all Automated Impella Controllers in Canada due to purge flag component failures that can affect device performance.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085702 for Phendimetrazine Tartrate Oral Capsule
Sandoz's oral capsule product PHENDIMETRAZINE TARTRATE (35 mg) under application ANDA085702 has received FDA approval; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Manufacturing Submissions for XYLOCAINE Ointment (NDA 008048)
The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Abbott's Calcium Gluceptate Injection (ANDA083159)
FDA approved Abbott's Calcium Gluceptate injection (ANDA083159) in 1972, with a supplemental manufacturing amendment in 1984; the product is now discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves KV PHARM Acetaminophen/Codeine Phosphate Tablet (ANDA085288)
FDA approved KV PHARM's oral tablet containing 300 mg acetaminophen and 30 mg codeine phosphate (ANDA085288). Multiple labeling submissions were filed; the product is now discontinued.
1