Regulatory Affairs
7 articles on Regulatory Affairs, researched and written by the Shotlee Editorial Team from primary sources.
US Regulators Consider Controversial Peptides Backed by RFK Jr.
The US Food and Drug Administration is evaluating the use of seven peptides, increasingly marketed for wellness and medical conditions. This review comes amidst soaring popularity, celebrity endorsements, and significant debate over their safety and efficacy.
8 min read
Beyond the Hype: Navigating the Rise of Online Peptides
A surge in injectable peptides marketed online for enhancement purposes is outpacing regulatory oversight, creating a 'grey zone' with potential public health implications. This article delves into the complexities, risks, and what consumers should understand.
6 min read
FDA Flags Chinese Supplier Over Risky GLP-1 Ingredient Practices
Concerns are mounting over the integrity of the pharmaceutical supply chain as the FDA takes action against a Chinese supplier for questionable practices involving critical GLP-1 drug ingredients. This development raises questions about the safety and reliability of active pharmaceutical ingredients used in popular weight loss and diabetes medications.
8 min read
FDA Proposes Curbs on Compounding Weight-Loss Drugs
The U.S. Food and Drug Administration (FDA) has proposed a significant change that could reshape the landscape of weight-loss drug accessibility. By suggesting the exclusion of key active ingredients from the list of drugs that outsourcing facilities can compound in bulk, the FDA aims to curb large-scale, unauthorized production of popular medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound).
7 min read
Dr. Reddy's Semaglutide Inches Closer to Canadian Market Approval
Dr. Reddy's Laboratories has announced a significant milestone in its pursuit of bringing its semaglutide injection to the Canadian market, having received Drug Identification Numbers (DINs) from Health Canada. This development signals progress in the regulatory review process and underscores the company's commitment to expanding access to this important medication.
7 min read
Time for Guardrails on GLP-1 Compounding: Safety Risks Exposed
America faces a crisis in unregulated compounded GLP-1 drugs, with FDA reporting 1,150 adverse events including hospitalizations and deaths. Exploiting shortages of semaglutide and tirzepatide, compounders flood the market with untested products, misleading consumers. Now, with the SAFE Drugs Act and FDA crackdowns, it's time to restore safety standards.
4 min read
RFK Jr. Misrepresents Ex-FDA Officials in Push to Lift Peptide Ban
Health Secretary RFK Jr. is pushing to lift the FDA's ban on 19 peptides used in compounding pharmacies, claiming the decision was illegal with no safety signals. But former FDA officials, including Janet Woodcock, say he misrepresents their views amid documented risks like immune reactions and trial fatalities. As demand surges via influencers, recent illnesses highlight the stakes in this regulatory battle.
6 min read