Articles by Dr. Yathendra
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A few years ago, if someone had asked me what kept a PV lead awake at night, my answer would probably have been inspections, compliance, or finding…
A few years ago, if someone had asked me what kept a PV lead awake at night, my answer would probably have been inspections, compliance, or finding…
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🚀 Day 1 at the 6th Edition Drug Safety Symposium 2026 – India Chapter! 🚀 The team from ** 4C Pharma Solutions** is excited to be exhibiting at…
🚀 Day 1 at the 6th Edition Drug Safety Symposium 2026 – India Chapter! 🚀 The team from ** 4C Pharma Solutions** is excited to be exhibiting at…
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Life isn’t always the same. After 15/16 years of successful corporate experience, I took a bold decision to dive into something else- a never thought…
Life isn’t always the same. After 15/16 years of successful corporate experience, I took a bold decision to dive into something else- a never thought…
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A 17-year-old turned to beetroot juice to tackle a problem the medical world has struggled with for years: detecting infections in wounds without…
A 17-year-old turned to beetroot juice to tackle a problem the medical world has struggled with for years: detecting infections in wounds without…
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Day 1 at #CMO #360 #Boston is just getting started! 🚀 Excited to kick off the day alongside industry leaders and innovators in clinical outsourcing…
Day 1 at #CMO #360 #Boston is just getting started! 🚀 Excited to kick off the day alongside industry leaders and innovators in clinical outsourcing…
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We’re excited to share that 4C Pharma Solutions will be attending the CMO Summit 360° in Boston from April 13–14, 2026. Recognized as the largest…
We’re excited to share that 4C Pharma Solutions will be attending the CMO Summit 360° in Boston from April 13–14, 2026. Recognized as the largest…
Liked by Dr. Yathendra Madineni
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Wishing everyone a very Happy Ugadi! May this new year bring fresh beginnings, clarity in decisions, and continued growth—both personally and…
Wishing everyone a very Happy Ugadi! May this new year bring fresh beginnings, clarity in decisions, and continued growth—both personally and…
Liked by Dr. Yathendra Madineni
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Meet Dr. Peder Seglund, Ph.D. at LSI USA 🇺🇸 We’re excited to be part of the LSI USA 2026, where innovation meets opportunity in the MedTech…
Meet Dr. Peder Seglund, Ph.D. at LSI USA 🇺🇸 We’re excited to be part of the LSI USA 2026, where innovation meets opportunity in the MedTech…
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At 4C Pharma Solutions LLC, our philosophy is simple: “4C-ing” your service and compliance needs before they become challenges. By anticipating…
At 4C Pharma Solutions LLC, our philosophy is simple: “4C-ing” your service and compliance needs before they become challenges. By anticipating…
Liked by Dr. Yathendra Madineni
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Mar 12, 2026: Stepping into shoes slightly bigger than my size, I will do my best to grow into them. I hope to walk in the footsteps of the many…
Mar 12, 2026: Stepping into shoes slightly bigger than my size, I will do my best to grow into them. I hope to walk in the footsteps of the many…
Liked by Dr. Yathendra Madineni
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Day 1 at the 40th Pharmacovigilance UK & EU 2026 in London is off to a fantastic start! It’s great to see so many industry leaders, experts, and…
Day 1 at the 40th Pharmacovigilance UK & EU 2026 in London is off to a fantastic start! It’s great to see so many industry leaders, experts, and…
Liked by Dr. Yathendra Madineni
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𝐕𝐂 𝐓𝐞𝐫𝐦 𝐒𝐡𝐞𝐞𝐭 𝐃𝐞𝐜𝐨𝐝𝐞𝐝 This framework breaks down the clauses that quietly determine ownership, control, and exit outcomes. Key…
𝐕𝐂 𝐓𝐞𝐫𝐦 𝐒𝐡𝐞𝐞𝐭 𝐃𝐞𝐜𝐨𝐝𝐞𝐝 This framework breaks down the clauses that quietly determine ownership, control, and exit outcomes. Key…
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I used NotebookLM to generate an infographic on PSUR using EMA GVP Module VII, and here is the result. #patientsafety #pbrer
I used NotebookLM to generate an infographic on PSUR using EMA GVP Module VII, and here is the result. #patientsafety #pbrer
Liked by Dr. Yathendra Madineni
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We’re thrilled to be exhibiting at the MedTech Conference in San Diego from October 5th to 8th! If you’re attending, stop by Booth 716 and meet the…
We’re thrilled to be exhibiting at the MedTech Conference in San Diego from October 5th to 8th! If you’re attending, stop by Booth 716 and meet the…
Liked by Dr. Yathendra Madineni
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I am excited to share that I have joined Amgen in Hyderabad, India as Senior Manager Global Patient Safety. Amgen strives to serve patients by…
I am excited to share that I have joined Amgen in Hyderabad, India as Senior Manager Global Patient Safety. Amgen strives to serve patients by…
Liked by Dr. Yathendra Madineni
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I’ve always felt that a workplace is just a workplace, and colleagues are, well, just colleagues. Calling them 'family' always seemed like a bit of a…
I’ve always felt that a workplace is just a workplace, and colleagues are, well, just colleagues. Calling them 'family' always seemed like a bit of a…
Liked by Dr. Yathendra Madineni
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Michael Milane, MD, MBA
Michael Milane, MD, MBA
University of California, Irvine - The Paul Merage School of Business
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Jagrut Vaishnav
Canada’s Drug Agency (CDA-AMC) Proposes Key Upgrades to Its Reimbursement Review Process CDA-AMC has launched a public consultation on several important updates to its drug reimbursement review framework. Consultation window: Jan 26 – Feb 26, 2026 These changes aim to modernize the process, improve transparency, and shorten timelines for patients, providers, and sponsors. Here’s what’s new: 🔹 Faster Review Timelines CDA proposes to streamline its end-to-end review process — reducing the time from initiation to final recommendation from 205 to 180 days. 🔹 Refined Reconsideration Procedures A new 40‑day embargo period to finalize recommendations is being introduced to bring more predictability of timelines and enhance transparency, especially around patient input. This alone is expected to shorten reviews by ~20 days. 🔹 Clear Pathways for Resubmissions For products that initially receive a “do not reimburse,” CDA-AMC plans to define explicit criteria for standard and streamlined resubmissions, enabling a more proportionate and efficient process when new evidence emerges. 🔹 Updated Eligibility for Testing Procedure Assessments (TPAs) CDA-AMC is expanding and clarifying eligibility for assessing complementary testing procedures — particularly important for precision‑based therapies. This includes clearer guidance on when TPAs are triggered and what pharmacoeconomic requirements apply. Overall, these proposals signal a meaningful shift toward greater procedural clarity, consistency, and accelerated access pathways. If you’re involved in market access, health policy, or evidence strategy, this consultation is worth watching closely. #canada #CDA #HTA #reimbursement #review
1 Comment -
AMIT KATOCH
News For November 2025, India's drug regulator, CDSCO, declared 205 drug samples Not of Standard Quality (NSQ), including common meds like Pantoprazole, Metformin, Telmisartan, and Bupivacaine, failing tests for quality/potency, with 64 flagged by Central Labs and 141 by State Labs, as part of routine checks for market safety. This monthly alert highlights ongoing quality issues in the supply chain, with specific batches failing due to not meeting Indian Pharmacopoeia (IP) standards. Key Details for November 2025: Total NSQ Samples: 205. Central Drug Labs: 64 samples flagged. State Drug Labs: 141 samples flagged. Examples of Flagged Drugs: Pantoprazole, Metformin, Telmisartan, Bupivacaine, Diazepam, Atorvastatin/Clopidogrel, Pheniramine Maleate. Reason for NSQ: Failure to meet specified quality parameters (e.g., dissolution, assay). Regards, JAKSTAR PHARMA
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