Regulatory Updates
Aug 30, 2026•1 min read
NECA Announces Revised Notice for Two PRP-Based Medical Technologies Approved in 2026
NECA reported that two autologous platelet‑rich plasma treatments – nasal injection and rotator‑cuff injection – were deemed safe and effective by the 4th New Medical Technology Evaluation Committee.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS to Amend Approval Conditions for Mycophenolate and Albendazole Products Based on FDA and EMA Safety Reviews
Korea’s MFDS is drafting a change order for mycophenolate and albendazole drug labels, incorporating safety findings from the US FDA and EU EMA, and has opened a public comment period.
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Regulatory Updates
Aug 30, 2026•1 min read
KRPIA Welcomes Korea’s First International Joint Drug Review via EMA’s OPEN Program
The Korea Research-based Pharmaceutical Industry Association (KRPIA) praised the MFDS for completing its first joint drug assessment with overseas regulators through EMA’s OPEN program, conducted simultaneously in Europe and Korea.
Regulatory Updates
Aug 30, 2026•1 min read
MFDS reviews removal of pediatric indication for dioctahedralsmektate antidiarrheal
South Korea’s MFDS is considering deleting the pediatric indication for the dioctahedralsmektate antidiarrheal after safety data were deemed insufficient, following proactive applications by manufacturers.
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Regulatory Updates
Aug 30, 2026•1 min read
MFDS Issues Draft Amendment Order for Opicapone Oral Formulations to Update Adverse Reaction Precautions
The Korean Ministry of Food and Drug Safety has prepared a draft amendment order for Opicapone oral drugs, revising the adverse‑reaction warnings and opening a public comment period.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Hikma Dronabinol Oral Capsules (ANDA 079217)
FDA approved Hikma's ANDA 079217 for oral Dronabinol capsules (2.5 mg, 5 mg, 10 mg); all listed products are currently marked discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANAGRELIDE (ANDA076811)
FDA has approved the generic oral capsule ANAGRELIDE under ANDA076811, covering 0.5 mg and 1 mg strengths, sponsored by Novitum Pharma and manufactured by ANI Pharmaceuticals.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Ranitidine Oral Syrup (ANDA077405)
The FDA has granted approval for ANDA077405, an oral Ranitidine hydrochloride syrup (15 mg/ml) manufactured by Pharmaceutical Associates, Inc., with labeling updates through 2010.
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Regulatory Updates
Aug 30, 2026•1 min read
PAMIDRONATE DISODIUM Injection Products Discontinued – ANDA077703
SUN Pharma Global's ANDA077703 for injectable pamidronate disodium (30 mg and 90 mg vials) has been marked discontinued by the FDA.
Regulatory Updates
Aug 30, 2026•1 min read
FDA scientists caution against easing peptide drug regulations for compounding pharmacies
FDA internal scientists advise against loosening controls on seven peptide ingredients intended for ulcerative colitis, insomnia and obesity, citing insufficient safety data.
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Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA 085208 for Hydrochlorothiazide 50 mg Oral Tablet (Discontinued)
The FDA approved ANDA 085208 for a 50 mg oral tablet of hydrochlorothiazide, now marked as discontinued, with supplemental manufacturing and labeling approvals spanning 1981‑2020.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Discontinues Technescan Gluceptate Injection (NDA018272)
The FDA lists Technescan Gluceptate, an injectable technetium‑99m diagnostic agent by Draximage, as discontinued under NDA018272. Submission history spans 1982‑2002.