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Filtering on: "topics distribution"

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FDA Extends Use Dates for Pfizer Injectables to Ease Shortage By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing

Tags: Pfizer, Hospira, Shortage

‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs By Zachary Brennan - Published 10 April 2017

A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs.

Categories: News, US, FDA, Distribution, Generic drugs, Government affairs

Tags: generic drug bill, pay for delay, REMS, delaying generic drug entry

Updated: FDA Offers Draft Q&A on Reporting Requirements for Wholesalers, Third-Party Logistics Providers By Zachary Brennan - Published 09 January 2017

The Food and Drug Administration (FDA) on Tuesday will release draft question-and-answer guidance, supplementing another draft from 2014, to help drug wholesale distributors and third-party logistics understand their annual reporting requirements.

Categories: News, US, FDA, Distribution, Drugs, Labeling, Packaging

Tags: DSCSA, wholesale drug distributor, drug logistics, FDA guidance

Danish Regulator Suspends Parallel Importer's GMP Certificate By Michael Mezher - Published 06 January 2017

The Danish Medicines Agency has suspended Danish parallel importer Europharma DK's manufacturing authorisation and good manufacturing practice (GMP) certificate over "serious breaches of compliance" uncovered during an inspection of the company's Esbjerg, Denmark site last month.

Categories: News, Europe, Compliance, Distribution, Drugs, Packaging

Tags: Danish Medicines Agency, Europharma DK

Companies Collaborate on DSCSA Guideline as Deadlines Approach By Zachary Brennan - Published 22 November 2016

Beginning next November, pharmaceutical companies will be required to mark their products with a National Drug Code (NDC), serial number, lot number and expiration date in both machine-readable and human-readable format thanks to the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: News, US, FDA, Business Skills, Distribution, Drugs, Government affairs, Labeling, Project management

Tags: GS1, traceability, pharmaceutical track and trace, serialization, DSCSA

Health Canada Issues New Medical Device Recall Guide By Michael Mezher - Published 04 November 2016

Health Canada on Thursday issued a new guide on medical device recalls detailing sponsors' responsibilities under the country's Medical Devices Regulations (MDR), replacing the agency's 2011 guidance.

Categories: News, Canada, Health Canada, Compliance, Distribution, Medical Devices, Product withdrawl and retirement

Tags: Medical Device Recalls

Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices By Zachary Brennan - Published 14 September 2016

The United Nations (UN) High-Level Panel on Access to Medicines released its long-awaited report on Wednesday with recommendations sure to rile up the pharmaceutical industry as it calls for World Trade Organization (WTO) members to no longer link the cost of research and development (R&D) with drug prices, as well as for an increase in the issuance of compulsory licenses and to require the disclosure of pharmaceutical R&D costs.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, WHO, Clinical, Distribution, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: UN High-Level Panel on Access to Medicines, UN reports on pharmaceuticals, compulsory licenses, pharmaceutical R&D

Novartis Subsidiary Pays $16m to Settle Charges of Illegally Shipping Drugs and Devices to Iran, Syria and Sudan By Zachary Brennan - Published 29 August 2016

Novartis subsidiary Alcon Laboratories has agreed to pay more than $16 million to settle allegations of manufacturing drugs and medical devices in the US and then shipping them to Iran, Syria and Sudan despite US trade embargoes that prohibit such sales.

Categories: News, Africa, Middle East, Distribution, Due Diligence, Government affairs, Medical Devices

Tags: Alcon Labs, Novartis, Iran, Syria, Sudan

FDA, International Authorities Shutter Thousands of Illegal Online Drug Stores By Michael Mezher - Published 09 June 2016

The US Food and Drug Administration (FDA) and other international regulators and law enforcement on Thursday announced the results of a series of actions to combat illegal and counterfeit medicines.

Categories: News, US, DOJ, FDA, Biologics and biotechnology, Distribution, Drugs

Tags: Pangea XI, Interpol, Counterfeit medicines

USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries By Zachary Brennan - Published 02 May 2016

The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four Asian countries.

Categories: News, Asia, Europe, Middle East, US, Biologics and biotechnology, Compliance, Distribution, Drugs

Tags: US trade representative, counterfeit drugs, Indian drug counterfeits, US trade partners for pharmaceuticals

Device Supplier Settles Monopoly Allegations With FTC By Zachary Brennan - Published 28 April 2016

UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market.

Categories: News, Europe, US, FTC, Business and Leadership, Crisis management, Distribution, Due Diligence, Manufacturing, Medical Devices, Regulatory strategy

Tags: PEEK, medical device suppliers, polymer suppliers, Invibio, Evonik, Solvay

Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries By Zachary Brennan - Published 26 April 2016

Ten years into the European Medicines Agency’s (EMA) regulatory experiment to try to increase access to medicines in low- and middle-income countries (LMICs) and the agency is seeing limited success, though enhancements outlined in a new report could increase the utility of the program.

Categories: News, Africa, Asia, Europe, Middle East, Oceania, EC, EMA, WHO, Biologics and biotechnology, Distribution, Drugs, Ethics, Government affairs, Preclinical, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Article 58, LMIC medicines, vaccines, tuberculosis, drug approvals, NRAs

IMS: Biosimilars Could Save Up to $110B in EU, US Through 2020 By Zachary Brennan - Published 29 March 2016

With 56 new biosimilars in clinical development, IMS Consulting Group says in a new report that the biologic competitors could save health systems across Europe and the US as much as $110 billion through 2020.

Categories: News, Europe, US, Biologics and biotechnology, Business Skills, Distribution, Reimbursement

Tags: IMS Health, biosimilar uptake, biosimilar savings

FDA: Explosions at Chinese Chemical Warehouse Contaminated Drugs By Zachary Brennan - Published 22 December 2015

The US Food and Drug Administration (FDA) on Tuesday alerted compounders and drug manufacturers that shipments from Tianjin, China may be at risk of chemical contamination following two massive explosions in August at a chemical warehouse there. 

Categories: News, China, US, CFDA, FDA, Active pharmaceutical ingredients, Crisis management, Distribution, Drugs, Government affairs, Product withdrawl and retirement, Quality, Regulatory intelligence

Tags: FDA, Tianjin, CFDA, chemical explosion, GSK

Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015) By Nick Paul Taylor - Published 22 December 2015

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

Categories: News, Asia, ANZTPA, CDSCO, CFDA, IMDRF, Medsafe, MFDS, PMDA, TGA, Biologics and biotechnology, Clinical, Distribution, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: Asia regulatory affairs, CFDA, TGA, CDSCO, PMDA

FDA Unveils New Office of Dietary Supplement Programs By Zachary Brennan - Published 21 December 2015

As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP).

Categories: News, US, FDA, Compliance, Distribution, Government affairs, Nutritional and dietary supplements, Quality

Tags: dietary supplements, supplement regulation, FDA and dietary supplements

In Focus: The Top News Stories from 2015 By Zachary Brennan - Published 21 December 2015

For RAPS’ Regulatory Focus, 2015 might simply be called: The Year of the Explainer.

Categories: News, Asia, Europe, Latin America and Caribbean, US, EMA, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Compliance, Distribution, Drugs, Due Diligence, Manufacturing, Medical Devices, Quality

Tags: biosimilars, priority review vouchers, 2015 RAPS, top regulatory news stories, Cures 2015

Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015) Published 17 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, CDSCO, DOJ, EMA, FDA, MHRA, TGA, Biologics and biotechnology, Business Skills, Combination products, Crisis management, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: Shkreli, generic drug pricing, Sarepta, biosimilars

Swedish Regulators Halt Imports from AstraZeneca’s Indian API Plant By Zachary Brennan - Published 15 December 2015

European imports from AstraZeneca’s now-closed terbutaline sulphate active pharmaceutical ingredient (API) manufacturing facility in Bangalore, India were halted by Sweden’s Medical Products Agency after failed validation runs, according to a recent notice in EudraGMDP.

Categories: News, Europe, EC, EMA, Active pharmaceutical ingredients, Clinical, Distribution, Drugs, Ethics, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: Medical Products Agency, EMA, AstraZeneca, Indian API manufacturing

Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015) By Nick Paul Taylor - Published 15 December 2015

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

Categories: News, China, India, Japan, Korea, Taiwan, CDSCO, CFDA, MHLW, Biologics and biotechnology, Clinical, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: CFDA, CDSCO, Korean biosimilars, drug applications

Regulatory Recon: FDA Settles Free Speech Suit Over Pacira Drug’s Label (15 December 2015) By Zachary Brennan - Published 15 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher , @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Asia, Europe, Oceania, US, EMA, FDA, ICH, MHRA, TGA, Active pharmaceutical ingredients, Advertising and Promotion, Biologics and biotechnology, Combination products, Compliance, Distribution, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices, Orphan products, Quality

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA

Indian Regulators, Medical Device Associations Focus on New Guidelines, Increasing Exports By Zachary Brennan - Published 11 December 2015

India’s Ministry of Health and Family Welfare (MOHFW) and the Central Drugs Standard Control Organization (CDSCO) met with medical device association representatives earlier this month to discuss how the country can become a hub for device manufacturing and begin to align with global regulations.

Categories: News, Asia, CDSCO, Clinical, Compliance, Crisis management, Distribution, Ethics, Government affairs, Medical Devices

Tags: India, medical device regulations, certificates of free sale, device exports

NIH Task Force Uncovers Major Issues at Suspended Drug Production Unit By Zachary Brennan - Published 11 December 2015

An internal task force at the National Institutes of Health (NIH) has found “widespread and longstanding” problems at its now-suspended pharmaceutical compounding arm, though the deficiencies were not found to have any direct harm on past or current clinical trial participants.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Compliance, Crisis management, Distribution, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Project management, Quality, Regulatory intelligence, Regulatory strategy

Tags: NIH, NIH drug manufacturing, FDA inspections, PDS, Francis Collins

FDA Warns Canadian API Manufacturer Following Adverse Event Reports By Zachary Brennan - Published 09 December 2015

After reports of serious adverse events surfaced for patients administered drug products compounded with an active pharmaceutical ingredient (API) from Quebec-based Medisca Pharmaceutique, the US Food and Drug Administration (FDA) inspected the company’s Pittsburgh-based site and found that the APIs were actually mislabeled and misbranded.

Categories: News, Canada, US, DOJ, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Distribution, Drugs, Government affairs, Postmarket surveillance, Quality

Tags: Medisca, somatropin, L-Citrulline, API manufacturing

Importers of FDA-Regulated Products Prepare for February Shift to Automated System By Zachary Brennan - Published 09 December 2015

In partnership with Customs and Border Protection (CBP) and 46 other government agencies, the Food and Drug Administration (FDA) has developed and is quickly transitioning to a new portal through which industry can electronically submit all data required by government agencies for international trade.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Combination products, Distribution, Drugs, Government affairs, Medical Devices, Orphan products, Quality

Tags: FDA imports, import alert, ACE, CBP