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Filtering on: "topics crisis management"

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Updated: FDA Form 483 for Celltrion May Offer a Glimpse Into Limited Uptake for Remicade Biosimilar By Zachary Brennan - Published 06 September 2017

The US Food and Drug Administration (FDA) on Wednesday released a Form 483 sent to Korea’s Celltrion with 12 observations, which an industry analyst believes could be the reason why the commercialization of Celltrion and Pfizer’s Inflectra (infliximab-dyyb), a biosimilar to Remicade, has not gone as well as planned in the US.

Categories: News, Asia, US, FDA, Biologics and biotechnology, Crisis management

Tags: Celltrion, Form 483, Pfizer, Inflectra

FDA Alerts on Risks From Merck’s Keytruda in Multiple Myeloma Following Halted Trials By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration (FDA) on Thursday released an alert and summary of findings from two halted Merck clinical trials evaluating the use of Keytruda (pembrolizumab) combined with other treatments in patients with multiple myeloma.

Categories: News, US, CDER, Biologics and biotechnology, Clinical, Crisis management, Drugs

Tags: Keytruda, Merck, multiple myeloma, FDA alert

FDA to Unveil New Regulatory Framework for Stem Cell Therapies By Zachary Brennan - Published 28 August 2017

The US Food and Drug Administration's (FDA) Commissioner Scott Gottlieb said Monday the agency this fall will advance a new framework to regulate stem cell therapies.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Government affairs, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: stem cell therapy, FDA on regenerative medicine, DTC stem cell clinics

States Take on Drug Price Transparency, Gouging By Zachary Brennan - Published 23 August 2017

As the US Congress continues to highlight specific drug price increases rather than adopt wide-reaching legislation to curb such practices, states are taking the matter into their own hands.

Categories: News, US, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: drug prices, drug price transparency

Pfizer Wins Indian Patent on Prevnar 13 Vaccine By Zachary Brennan - Published 22 August 2017

India’s patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims.

Categories: News, Asia, Europe, US, Crisis management, Drugs, Regulatory strategy

Tags: Prevnar 13, Pfizer, PCV, pneumonia vaccine

FDA Explains Emergency Expanded Access Application Process By Zachary Brennan - Published 18 August 2017

The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment use in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: expanded access, Right to Try, emergency IND

Congressmen Investigate 'Shadow Pricing' of MS Drugs By Zachary Brennan - Published 17 August 2017

Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS).

Categories: News, US, Crisis management, Drugs

Tags: MS drug prices, Teva, Bayer, Welch

FDA Considers WHO Scheduling Change for 17 Drug Substances By Zachary Brennan - Published 11 August 2017

The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs.

Categories: News, US, FDA, WHO, Crisis management, Drugs, Government affairs

Tags: drug substances, fentanyl, opioids, cannabis

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Medical Devices

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

FDA Warns Indian Manufacturer for Equipment in 'State of Disrepair' By Zachary Brennan - Published 11 July 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to an India-based pharmaceutical manufacturer for equipment "in a state of disrepair" and failures in validating a manufacturing process for a drug that was distributed in the US from 2014 to 2016.

Categories: News, Asia, US, FDA, Crisis management, Drugs, Manufacturing

Tags: warning letter, Vista Pharmaceuticals, isoxsuprine hydrochloride

Endo Pulls Opioid From US Market at FDA's Request By Zachary Brennan - Published 06 July 2017

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Product withdrawl and retirement

Tags: Endo, Opana ER, opioids, opioid crisis

Novo Nordisk Warns of Possible Cracks in Insulin Devices By Zachary Brennan - Published 05 July 2017

Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents.

Categories: News, Canada, US, Crisis management, Due Diligence, Medical Devices

Tags: Novo Nordisk, insulin pen, insulin device, NovoPen Echo, NovoPen 5

Chinese Heparin Contamination Questions Return With New FDA Warning Letter By Zachary Brennan - Published 05 July 2017

The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, Chinese heparin, heparin contamination, FDA warning letters

British Ministers Call for Post-Brexit Cooperation With EMA By Zachary Brennan - Published 03 July 2017

UK health minister Jeremy Hunt and business minister Greg Clark on Monday wrote a letter to the Financial Times calling for the UK to continue working with the European Medicines Agency after Brexit.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, Jeremy Hunt, EMA post-Brexit

ABPI Extends Astellas UK Suspension for 12 More Months By Zachary Brennan - Published 28 June 2017

The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."

Categories: News, Europe, Compliance, Crisis management, Ethics

Tags: ABPI, Astellas, prescribing information

AdvaMed Urges Supreme Court to Take Up Case on 510(k) Review Process By Zachary Brennan - Published 27 June 2017

Does a medical device cleared under the US Food and Drug Administration's 510(k) review process mean that it is safe or that the device is just "substantially equivalent" to a legally marketed device? That's the question industry group AdvaMed wants the US Supreme Court to answer.

Categories: News, US, FDA, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: SCOTUS, Supreme Court, AdvaMed, 510(k)

US FDA Sees Major Spike in BA/BE Studies in India By Zachary Brennan - Published 19 June 2017

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs

Tags: BA and BE studies, bioequivalence, generic drugs from India

Senate Committee Takes First Step on Rising Pharmaceutical Prices By Zachary Brennan - Published 13 June 2017

The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Government affairs, Regulatory intelligence, Research and development

Tags: Senate HELP, drug prices, Pew, Manhattan Institute, Johns Hopkins, pharmaceutical prices

Asia Regulatory Roundup: India Sets Guidelines for Fixed-Dose Combination Trials (13 June 2017) By Nick Paul Taylor - Published 13 June 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Crisis management, Drugs, Government affairs

Tags: Asia Regulatory Roundup, India clinical trials, CFDA guidance

Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same? By Zachary Brennan - Published 12 June 2017

The Senate Health, Education, Labor & Pensions (HELP) committee is holding a hearing Tuesday on prescription drug costs and will look to address how the drug delivery system affects what patients pay.

Categories: News, US, FDA, Crisis management, Drugs, Government affairs

Tags: Senate HELP, Mylan, Valeant, Turing, drug prices

European Commission and EMA Offer Guidance on Brexit for Pharma Companies By Zachary Brennan - Published 31 May 2017

As marketing authorisation holders (MAHs) based in the UK begin to form plans to transfer their marketing authorizations (MAs) to holders established in EU member states, Norway, Iceland and Liechtenstein, the European Medicines Agency (EMA) and European Commission on Wednesday released guidance to prepare industry for the UK’s withdrawal from the EU.

Categories: News, Europe, EC, EMA, Crisis management, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, QPPV, PSMF, batch release, orphan products, MAHs and Brexit

Challenges Providing Pharmaceutical Products to Syrian Refugees By Zeina Sahloul - Published 24 May 2017

This article discusses the difficulties encountered by medical personnel working with refugees in Syria and delivering pharmaceutical products. It describes relevant regulatory policy and guidance for drug procurement and quality.

Categories: Features, Middle East, WHO, Crisis management, Drugs, Submission and registration

Tags: Syrian Refugee Crisis, Prequalification, UNHCR, Essential Medicines, MSF

FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures By Zachary Brennan - Published 23 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Crisis management, Manufacturing

Tags: FDA warning letters, China API manufacturers

Gottlieb Establishes FDA Committee to Confront Opioid Crisis By Zachary Brennan - Published 23 May 2017

Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee

FDA to Drug Manufacturers: Beware Water-Borne Contaminants By Zachary Brennan - Published 22 May 2017

With a crop of recent product recalls due to Burkholderia cepacia complex (BCC) contamination, the US Food and Drug Administration (FDA) on Monday warned drug manufacturers of non-sterile, water-based drug products of the dangers that BCC and other water-borne opportunistic pathogens pose.

Categories: News, US, FDA, Crisis management, Manufacturing

Tags: pharmaceutical contamination, FDA on contamination, BCC, water contaminants