#DrugRegulation

CITI Program

@citiprogram.org

3 weeks ago

FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs Today, the U.S. Food and Drug Administration is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies

The FDA is announcing its intent to take decisive steps to restrict GLP-1 APIs intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies as similar alternatives to FDA-approved drugs.
https://post.citiprogram.org/4ay9sFz
#FDA #GLP1 #DrugRegulation

Atul Shukla

@atulcorpbiz.bsky.social

1 month ago

How CDSCO Ensures Drug Safety & Quality in India | Zepky In India, medicines and medical devices play a very important role in protecting public health. From life-saving drugs to simple pain relief tablets, people trust that these products are safe and effe...

CDSCO Online Registration & Drug Safety Rules Explained

Understand how CDSCO regulates drugs, cosmetics, and medical devices in India.

Read more - zepky.com/blogs/10123/...

#CDSCOOnlineRegistration #DrugRegulation #MedicalDeviceImport #CosmeticManufacturingLicense

Citizen Portal News Virginia

@citizenptnewsva.bsky.social

1 month ago

Subcommittee hears bill to allow over‑the‑counter ivermectin; proponents stress access, opponents urge caution Sen. Cyphers presented SB545 to permit over‑the‑counter sales of ivermectin; proponents cited WHO essential‑medicine listing and rural access, while others raised concerns about politicization and side effects; committee moved to report the bill after debate.

Virginia's Senate is considering a bill that could make ivermectin available over-the-counter, sparking a heated debate on access versus safety.

Click to read more!

#VA #CitizenPortal #PublicSafety #PatientAccess #VirginiaHealthcare #DrugRegulation

Citizen Portal News US

@citizenptnewsus.bsky.social

1 month ago

Webinar Q&A: Colorado DUI inference, field‑kit limits and which materials can be quantified In RTI's webinar Q&A, Colorado and Virginia lab directors addressed whether labs must measure total THC (state‑by‑state), Colorado's 5 ng/ml permissible inference for THC in DUI cases, and limitations quantifying non‑plant products such as vape cartridges and creams.

Discover the crucial insights shared during the webinar on THC measurement, DUI standards in Colorado, and the challenges of quantifying cannabis products beyond plant material.

Learn more here

#US #CannabisStandards #ColoradoCannabis #DrugRegulation #PublicSafety #CitizenPortal

Jim Cox

@bisasquatch.bsky.social

2 months ago

‘She has no expertise’: the US medical community girds for Tracy Beth Høeg’s tenure at the FDA The Danish American who doubted Covid shots is meant to lead drug regulation – but has focused on vaccines

#Healthcare #DrugRegulation #Vaccines

www.theguardian.com/us-news/2025...

Pure Tech

@puretech.news

3 months ago

More FDA drama: Top drug regulator calls it quits after 3 weeks The top drug regulator at the Food and Drug Administration, Richard Pazdur, has decided to retire from the agency just three weeks after taking the leading position, according to multiple media outlets....

More FDA drama: Top drug regulator calls it quits after 3 weeks #Technology #Business #Other #FDA #DrugRegulation #HealthNews

Citizen Portal News Massachusetts

@citizenptnewsma.bsky.social

3 months ago

Mass. working group weighs oversight of xylazine; DPH warns against straight scheduling A state working group heard Department of Public Health testimony opposing immediate scheduling of xylazine, urged better data collection on sources and prevalence, and split into subgroups to prepare findings and a Dec. 11 presentation for the commission.

Massachusetts lawmakers are grappling with the rising presence of xylazine in the drug supply, debating whether to regulate this animal tranquilizer and its implications for public health.

Learn more here!

#MA #CitizenPortal #SubstanceAddiction #PublicHealth #DrugRegulation

JCS/T2D - A Diabetes Journey

@jcst2d.bsky.social

3 months ago

Wegovy 2.4 mg pens

Why Wegovy isn’t headed for OTC status—what the sources really say, why GLP-1 therapies don’t fit OTC criteria & why the conversation matters in obesity treatment.

jcst2d.com/index.php/ar...

#Wegovy #GLP1 #ObesityTreatment #DrugRegulation #MedicationSafety

Citizen Portal News Illinois

@citizenptnewsil.bsky.social

3 months ago

Kankakee‑area enforcement group briefs Manteno trustees on kratom; board to consider local ban Agents from the Kankakee Area Metropolitan Enforcement Group described kratom’s opioid‑like effects, potential for addiction and psychosis, and patchwork local restrictions; trustees discussed veterans’ use for PTSD and possible local ordinance or licensing measures and asked staff to gather more information.

Kratom, often marketed as a harmless herbal supplement, is raising alarms among local officials for its opioid-like effects and the dangers of unregulated sales.

Get the details!

#MantenoKankakeeCounty #IL #CitizenPortal #MantenoVeterans #PublicHealth #DrugRegulation #CommunitySafety

Pure Tech

@puretech.news

4 months ago

RFK Jr.’s FDA Is Now Also In Turmoil Over Corrupt Drug Regulator While we’ve talked quite a bit about the horror show that is RFK Jr.’s position as Secretary of HHS, most of the focus of those posts has been around what is happening at the CDC. And for good reason,...

RFK Jr.’s FDA Is Now Also In Turmoil Over Corrupt Drug Regulator #Technology #Other #RFKJR #FDA #DrugRegulation

@vaalsalya.bsky.social

4 months ago

#BrokenRepublic #India
@sakie339
The #deaths of #children in #Chhindwara in #MadhyaPradesh from #coughsyrup adulterated with #diethyleneglycol ( #DEG) have laid bare the #gaps in #drugregulation, from the #manufacturing site down to the #pharmacist.

ijme.in/articles/deg...

Citizen Portal News Michigan

@citizenptnewsmi.bsky.social

4 months ago

Bills would require manufacturers to fund NPLEx transactions and modernize online pseudoephedrine sales Representatives Bagole and McFaul presented a two‑bill package to preserve Michigan's NPLEx electronic blocking system by requiring manufacturers who sell pseudoephedrine products in Michigan to pay for their product transactions, and to allow online/curbside transactions while maintaining ID checks and purchase limits.

Michigan is taking a bold step to modernize pseudoephedrine sales while ensuring public safety by requiring manufacturers to fund the electronic system that blocks illicit sales.

Learn more here!

#MI #CitizenPortal #ConsumerProtectiveLaws #PublicHealthSafeguards #DrugRegulation

Pure Tech

@puretech.news

4 months ago

FDA described as a “clown show” amid latest scandal; top drug regulator is out An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the latest scandal at the Food and Drug Administration, an agency that industry outsiders...

FDA described as a “clown show” amid latest scandal; top drug regulator is out #Technology #Business #IndustryGiants #FDA #DrugRegulation #HealthcareScandal

One Health Trust

@onehealthtrust.bsky.social

4 months ago

Asia’s influenza surge; Contaminated medicines in India This week’s digest covers Asia’s influenza surge, contaminated medicines in India, climate-health information systems in Latin America, & more

For #OneHealthDay, check out our latest roundup of One Health research and news.

Check out the digest here: onehealthtrust.org/news-media/w...

#healthinformationsystem #latinamerica #healthinformation #drugregulation #onehealth #climate #rabies #chagas

Observe Lebanon

@observelebanon.bsky.social

4 months ago

Image from image_1.jpg

A man in Beit Lif, Lebanon, was arrested for illegally practicing medicine at home, using unauthorized drugs, including expired and smuggled medications. This incident reveals serious public health concerns and challenges in medical regulation. #Lebanon #PublicHealth #DrugRegulation

News X

@news-x.bsky.social

5 months ago

😠 Outrage after scandals like Gambia & Uzbekistan rarely leads to accountability. ⚖️ MP deaths are a 🚨 warning: rebuild trust & strengthen pharma regulation NOW! 🛡️ #DrugRegulation #PatientSafety #Healthcare 🧵

News X

@news-x.bsky.social

5 months ago

😠 Outrage after scandals rarely leads to accountability. ⚖️ Firms face minimal consequences. 😔 Rebuilding public trust 🤝 requires urgent action & systemic reform! #DrugRegulation #PatientSafety #IndiaHealth 🧵

News X

@news-x.bsky.social

5 months ago

This is a critical 🚨 public health issue. Strict quality control & vigilant monitoring are vital to protect vulnerable populations from dangerous, contaminated meds. 🛡️ #DrugRegulation #Healthcare #SafetyFirst 🧵

News X

@news-x.bsky.social

5 months ago

5/6 A SIT is investigating the supply chain 📦 & accountability at Sresan Pharmaceuticals. 👮‍♀️ This highlights critical gaps in drug regulation & the urgent need for stricter quality control measures. ⚠️ #DrugRegulation #SafetyFirst

News X

@news-x.bsky.social

5 months ago

7/8 Union Health Sec. held a high-level meeting emphasizing strict compliance w/ Revised Schedule M (drug manufacturing practices) & rational cough syrup use, esp for 👶. #DrugRegulation #QualityControl #PatientSafety

News X

@news-x.bsky.social

5 months ago

3/6 📉 CDSCO inspected 💊 manufacturing units in 6 states, focusing on 19 drugs (cough syrups & antibiotics) after similar incidents. Urgent action needed to protect vulnerable populations! #DrugRegulation #CDSCO #PatientSafety

News X

@news-x.bsky.social

5 months ago

4/5 👮‍♀️ Drugs inspectors ordered to freeze 🧊 existing stock, stop further sales, & collect samples for testing. Vigilance on drug movement intensified. #DrugRegulation #MPHealth #Enforcement

News Analysis

@newsanalysis.com

6 months ago

Under Trump, FDA seeks to abandon expert reviews of new drugs FDA under Trump admin. considering ending expert drug reviews. This decades-old policy provides pub...

FDA under Trump admin. considering ending expert drug reviews. This decades-old policy provides public scrutiny of agency decisions. Critics argue the change lacks transparency. #DrugRegulation #News

News2Image

@news2image.bsky.social

6 months ago

Fear of serious health risks due to the increase in the supply of illegal drugs

#AIArt #NewsArt #DALLE #IllegalDrugs #HealthRisks #Obesity #Diabetes #PublicHealth #DrugSafety #SocialMediaAds #HealthAwareness #DrugRegulation #ConsumerProtection #HealthInspection #NuNL #MedicalEthics #FakeMedications

The Daily Historian

@thedailyhistorian.bsky.social

7 months ago

Her story reminds us that one person’s insistence on due process can change millions of lives and shape the course of public health.

Follow the page for more daily history posts!

#FrancesKelsey #ThalidomideCrisis #DrugRegulation #FDA #ScientificIntegrity #Thalidomide

Citizen Portal News Massachusetts

@citizenptnewsma.bsky.social

7 months ago

Board Discusses Kratom Regulation Proposals Including Age Restrictions and Synthetic Bans Board members propose age limits and synthetic drug bans for kratom sales.

The Northampton Board of Health is taking bold steps to regulate kratom, proposing age limits and bans on synthetic variants to combat its rising presence in the illicit drug market.

Click to read more!

#MA #YouthProtection #CitizenPortal #PublicSafety #DrugRegulation

Profit Trading USA

@profittradingusa.bsky.social

7 months ago

Novo Nordisk faces ’show me’ moment to boost Wegovy growth after US copycat ban By Maggie Fick LONDON (Reuters) -A U.S. ban on copycat versions of Novo Nordisk (NYSE:NVO)’s Wegovy has begun to lift use of the weight loss drug, but the company will need to show more robust growth in the months ahead to bolster market confidence, investors and analysts say. New Wegovy prescriptions have increased by about 33% since May 22, when a U.S. Food and Drug Administration ban on so-called compounded versions of Wegovy took effect, amounting to 181,200 in the week ended July 18, according to data from IQVIA that was shared with Reuters by industry analysts. Total Wegovy prescriptions have also increased, narrowing the lead for Eli Lilly (NYSE:LLY) and Co’s Zepbound. In the week ended May 23, U.S. Zepbound prescriptions exceeded Wegovy by nearly 175,000. By July 18, the gap was about 133,000. Early signs of a shift come at a critical juncture for Novo. After Wegovy’s initial stunning success, investor confidence was rattled when Zepbound and compounders started to slow the drug’s growth. And then in May, the Danish company cut its full-year sales and earnings forecasts and announced the surprise exit of Chief Executive Lars Fruergaard Jorgensen, citing market challenges and a stock price nearly 60% below its 2024 peak. Jorgensen said at the time he expected the FDA compounding ban to lift sales in the second half of this year. Investors are keen to hear whether that is still likely when the company reports quarterly earnings on August 6. That leaves the drugmaker in what Barclays analyst Emily Field called a "show me" phase - no longer buoyed by optimism about a turnaround but under pressure to deliver. She has an "overweight" rating on Novo’s shares. "We thought this trajectory change (in new prescriptions) would get the shares moving, but not so far," Berenberg analyst Kerry Holford told Reuters. "I suspect investors are now waiting for the (second quarter) update - will they/won’t they trim guidance range? I think they will trim the top." Berenberg has a "hold" rating on Novo. Novo did not respond to a request for comment. Investors and analysts note that the IQVIA prescription data is incomplete, because it does not capture sales of Wegovy through the company’s direct-to-consumer platform, NovoCare, launched in March. They estimate the channel is still a small slice of overall Wegovy volume. "We would hope to see strong growth from the NovoCare channel but are cognizant that this may come at initially lower prices" due to discount offers, said Marcus Morris-Eyton, a portfolio manager at Alliance Bernstein, whose fund holds Novo shares. "Sentiment towards Novo Nordisk is currently exceptionally weak, but given low expectations, the low valuation and hopefully accelerating prescription data in (the second half of 2025) we believe the market is underestimating Novo’s long term growth potential," he said. BRINGING BACK PATIENTS Booming sales of Wegovy catapulted Novo to become Europe’s most valuable listed company, peaking in June 2024 at about 615 billion euros, after the weekly injection became the first highly-effective obesity treatment approved in the U.S. in 2021. But supply disruptions and gaps in health insurance coverage for Wegovy helped fuel the market for cheaper compounded - or copycat - versions, which are allowed under U.S. law when drugs are in shortage. Investor sentiment on Novo soured after the company lost ground to U.S. rival Eli Lilly, which launched Zepbound in late 2023. In its first full-year forecast downgrade since Wegovy’s launch, Novo said in May it expected local-currency sales growth of 13–21%, down from a previous forecast of 16–24%. Operating profit growth is projected at 16–24%, versus 19–27% previously. Capturing more of the patients who had turned to compounded drugs is key to meeting those targets. The FDA determined that Wegovy was no longer in shortage in February, leading to the ban on compounded versions. Novo has rolled out new tactics to bring patients back, including a limited-time discount for one month’s supply, and secured better coverage from insurer CVS Health (NYSE:CVS). Analysts at Berenberg and UBS are sceptical these moves will provide enough momentum and expect that Novo will reduce or narrow its full-year guidance ranges, according to research notes. TD Cowen said the outcome was hard to predict due to limited visibility on NovoCare. Bank of America and Guggenheim said they did not expect another guidance cut and Barclays said it was unlikely. ($1 = 0.8513 euros) Before you buy stock in LLY, consider this: ProPicks AI are 6 easy-to-follow model portfolios created by Investing.com for building wealth by identifying winning stocks and letting them run. Over 150,000 paying members trust ProPicks to find new stocks to buy – driven by AI. The ProPicks AI algorithm has just identified the best stocks for investors to buy now. The stocks that made the cut could produce enormous returns in the coming years. Is LLY one of them?

Click Subscribe #NovoNordisk #Wegovy #WeightLoss #Pharmaceuticals #DrugRegulation

Profit Trading USA

@profittradingusa.bsky.social

7 months ago

FDA to appoint George Tidmarsh as top drug regulator, Bloomberg News reports (Reuters) -U.S. Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the director of the Center for Drug Evaluation and Research, Bloomberg News reported on Monday, citing a person familiar with the decision. The Department of Health and Human Services, which oversees the FDA, did not immediately respond to a Reuters request for comment. Tidmarsh also did not immediately respond to email and LinkedIn requests for comment. AI computing powers are changing the stock market. Investing.com's ProPicks AI includes 6 winning stock portfolios chosen by our advanced AI. In 2024 alone, ProPicks AI identified 2 stocks that surged over 150%, 4 additional stocks that leaped over 30%, and 3 more that climbed over 25%. Which stock will be the next to soar?

Click Subscribe #FDA #GeorgeTidmarsh #DrugRegulation #Biotech #Healthcare

Profit Trading USA

@profittradingusa.bsky.social

7 months ago

Click Subscribe #FDA #Biotech #DrugRegulation #Healthcare #Pharmaceuticals

Citizen Portal News California

@citizenptnewsca.bsky.social

8 months ago

Assemblymember advocates for regulation of dangerous xylazine in fentanyl products Assemblymember highlights xylazine's lethality and lack of addiction risk in fentanyl mix

The Assembly Public Safety Committee is sounding the alarm on Xylazine, a hidden threat in fentanyl products that could be more lethal than you think.

Learn more here

#CA #CitizenPortal #OpioidCrisis #PublicHealth #DrugRegulation