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Filtering on: "topics crisis management"

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Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

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

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

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

Tags: heparin, China heparin, House E&C, FDA investigations

FDA Warns of Increased Risk of Serious Pancreatitis with Allergan’s Viberzi By Zachary Brennan - Published 15 March 2017

Following the death of two patients without a gallbladder on Allergan’s irritable bowel drug Viberzi (eluxadoline), the US Food and Drug Administration (FDA) on Wednesday warned about the increased risk of serious pancreatitis in such patients.

Categories: News, US, FDA, Crisis management, Drugs, Postmarket surveillance

Tags: Viberzi, pancreatitis, Viberzi deaths, gallbladder

FDA Transparency: Agency’s Hands Tied by its own Regulations By Zachary Brennan - Published 15 March 2017

Ask a US Food and Drug Administration (FDA) official how many biosimilar applications are actually under review, or the details of a recent Complete Response Letter (CRL), and he or she will explain how the agency cannot offer any more details than what is already publicly known, even if what has been made public is not aligned with reality.

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

Tags: FDA transparency, CRLs, biosimilars

Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice By Zachary Brennan - Published 14 March 2017

When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice.

Categories: News, Europe, MHRA, Biologics and biotechnology, Compliance, Crisis management, Drugs, Ethics

Tags: Celgene, Takeda, Pierre Fabre, PMCPA, ABPI

Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs By Zachary Brennan - Published 06 March 2017

The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs).

Categories: News, Asia, Canada, Europe, US, EC, FDA, Health Canada, MHRA, TGA, WHO, Crisis management, Government affairs, Manufacturing

Tags: PIC/S, good manufacturing practice for ATMP, European Commission consultation

FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables By Zachary Brennan - Published 28 February 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.

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

Tags: Pfizer, Hospira, Copaxone, Teva, warning letter

FDA Continues to Reduce Generic Drug Backlog By Zachary Brennan - Published 22 February 2017

The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.

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

Tags: ANDA approvals, generic drug backlog, generic drug dashboard

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike By Zachary Brennan - Published 14 February 2017

Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

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

Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices

EMA Reviews Safety of PAH Medicine Following 5 Deaths in France By Zachary Brennan - Published 14 February 2017

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs

Tags: Uptravi, PRAC, Actelion

Sanders, Cummings Slam Marathon’s $89,000 Price Tag for Old Steroid By Zachary Brennan - Published 13 February 2017

Sen. Bernie Sanders (D-VT) and Rep. Elijah Cummings (D-MD) on Monday wrote to Illinois-based Marathon Pharmaceuticals CEO Jeffrey Aronin, calling the company’s plan to charge $89,000 annually for its recently approved treatment “outrageous.”

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

Tags: Marathon, Emflaza, Deflazacort, steroid, DMD

FDA Warns of Risks From Fluid-Filled Stomach Balloons to Treat Obesity By Zachary Brennan - Published 09 February 2017

The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers noting the receipt of dozens of reports for two different types of adverse events linked to fluid-filled intragastric balloons used to treat obesity. 

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

Tags: fluid-filled intragastric balloons, obesity treatment, obesity, balloon system

Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk By Zachary Brennan - Published 07 February 2017

Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB).

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

Tags: hiring freeze, FDA employee vacancies, FDA hiring, Upton, DeGette, OMB

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance By Zachary Brennan - Published 06 February 2017

The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward.

Categories: Compliance, Crisis management, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: "two out, one in," Trump regulatory policy, FDA regulations

Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated By Zachary Brennan - Published 31 January 2017

In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.”

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

Tags: Trump, FDA regulations, pharmaceutical CEOs, Trump meeting

FDA Bans Imports of Piston Syringes From Nipro’s Thailand Site By Zachary Brennan - Published 25 January 2017

The US Food and Drug Administration (FDA) on Tuesday added Nipro’s Thailand site to a list of companies barred from shipping supplies of medical devices to the US because of a lack of quality.

Categories: News, Asia, US, FDA, Crisis management, Medical Devices, Quality

Tags: Nipro, piston syringes, FDA import alert

Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo By Zachary Brennan - Published 24 January 2017

A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner spoke with Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence

Tags: FDA commissioner, Gulfo, Trump and FDA

Doctors Without Borders Objects to Sanofi Receiving an Exclusive License for a Zika Vaccine By Zachary Brennan - Published 24 January 2017

Doctors Without Borders (MSF) on Monday objected to the US government’s granting of an exclusive patent license to Sanofi Pasteur for a developing Zika vaccine, though Sanofi on Tuesday explained the risks of developing such a vaccine.

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

Tags: Zika, MSF, Sanofi Pasteur, Zika vaccine

ICH Working Group to Provide More Detailed Guidance By Zachary Brennan - Published 23 January 2017

The International Council on Harmonisation (ICH) on Monday outlined a proposal to extend the remit of the Points to Consider (PtC) Working Group to provide more detailed guidance, examples and “Questions and Answers” on topics of regulatory importance such as data quality, medication errors and product quality issues.

Categories: News, Canada, Europe, US, ICH, Clinical, Crisis management, Drugs, Quality

Tags: MedDRA, pharmaceutical company guidance, medication errors

Truthful and Non-Misleading: FDA Looks to Clarify Policies on Medical Product Communications By Zachary Brennan - Published 18 January 2017

When is off-label marketing considered free speech? And when should such communications, whether they are directed at doctors, insurers or the public, be considered in violation of the law or US Food and Drug Administration (FDA) regulations?

Categories: News, US, FDA, Advertising and Promotion, Compliance, Crisis management, Labeling, Regulatory intelligence, Regulatory strategy

Tags: off-label drug communications, off-label marketing, First Amendment and pharmaceuticals, FDA guidance

Drug Compounding With Bulk Substances: FDA Offers Interim Policies By Zachary Brennan - Published 16 January 2017

The US Food and Drug Administration (FDA) late Friday issued revised versions of two final guidance documents explaining the use of bulk drug substances in compounding and clarifying that the agency does not intend to take action against certain outsourcing facilities and compounded drugs.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Quality

Tags: drug compounding, compounded drugs, 503A, 503B, FDA interim policy

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

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

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

Mammogram Record Retention: FDA Offers Advice By Zachary Brennan - Published 05 January 2017

Following some confusion over mammogram record retention requirements, the US Food and Drug Administration (FDA) on Thursday told all facilities conducting such tests that they must retain a record of each one for at least five years, or not less than 10 years if no additional mammograms of the patient are performed at the facility (or a longer period if mandated by state or local law).

Categories: News, US, CDRH, Crisis management, Medical Devices, Quality, Regulatory intelligence

Tags: mammogram, FDA and mammography, MQSA

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP