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Filtering on: "topics manufacturing"

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FDA Warns Chinese API Maker for Data Integrity Issues By Michael Mezher - Published 21 June 2017

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: Data Integrity

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

Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

FDA Warns B. Braun Medical’s California Plant for Repeat Violations By Zachary Brennan - Published 31 May 2017

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to B. Braun Medical’s Irvine, CA-based manufacturing facility for repeat violations also uncovered during inspections in 2013, 2014 and 2015.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: B. Braun Medical, FDA warning letters, field alert reports, leaking IV bags

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

Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017) By Nick Paul Taylor - Published 23 May 2017

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

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

10 Hot-Button Issues FDA’s New Commissioner Will Face By Zachary Brennan - Published 11 May 2017

Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Scott Gottlieb, FDA commissioner, LDTs, Cures, opioids, off-label marketing, regulatory convergence

FDA Warns Lonza’s Class II Device Manufacturing Site By Zachary Brennan - Published 09 May 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

Categories: News, US, CDRH, Biologics and biotechnology, Compliance, Crisis management, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Lonza, medical device manufacturing, FDA warning letter

FDA Warns Indian Firm for Impeding Inspection By Michael Mezher - Published 09 May 2017

The US Food and Drug Administration (FDA) in April warned Indian pharmaceutical manufacturing company Vikshara Trading & Investments Ltd for attempting to avoid an inspection by pretending its employees were on strike and for poor conditions inside its facility.

Categories: News, India, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspection, Warning Letter

FDA Official Highlights Foreign Supply Chain Challenges By Michael Mezher - Published 05 May 2017

Drugmakers should be mindful of the risks involved with relying on foreign manufacturers as part of their supply chain, said Thomas Cosgrove, director of the US Food and Drug Administration's (FDA) Office of Manufacturing Quality within the Center for Drug Evaluation and Research.

Categories: News, US, FDA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Office of Manufacturing Quality, Foreign Inspections, Supply Chain

New FDA Warning Letter, Form 483 for Two Indian Companies By Michael Mezher - Published 02 May 2017

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic drugmaker Aurobindo Pharma.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Compliance, Manufacturing

Tags: Warning Letter, Form 483

FDA Issues Form 483 for Lupin's Goa Facility By Michael Mezher - Published 28 April 2017

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

Categories: News, India, US, FDA, Generic drugs, Manufacturing

Tags: Form 483, Lupin

EMA-FDA QbD Pilot Program Led to Further Harmonization By Zachary Brennan - Published 19 April 2017

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have wrapped up a joint pilot program assessing applications containing Quality by Design (QbD) elements that led to further hamornization of concepts introduced through the International Council for Harmonisation (ICH).

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: QbD pilot, EMA-FDA joint program, quality by design

MHRA Investigates GMP Deficiency Trends From 2016 By Zachary Brennan - Published 18 April 2017

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Tuesday released a new report on the trends seen from inspecting pharmaceutical manufacturing plants and evaluating their good manufacturing practices (GMPs).

Categories: News, Europe, MHRA, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: GMP deficiencies, pharmaceutical inspections, GMP deficiency trends

Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council By Zachary Brennan - Published 17 April 2017

Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: J&J, Pfizer, Allergan, combination products and FDA

WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site By Zachary Brennan - Published 12 April 2017

A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement.

Categories: News, China, US, FDA, WHO, Active pharmaceutical ingredients, Manufacturing

Tags: birth control, Plan B, pre-qualified manufacturers, API manufacturer

Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco By Zachary Brennan - Published 12 April 2017

Goa, India-based contract manufacturer Indoco Remedies received a US Food and Drug Administration (FDA) warning letter late last month after the agency said its failure to comply with current good manufacture practices (CGMP) may significantly affect the quality, safety and efficacy of the drugs it manufactures.

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

Tags: FDA warning letter, Indoco Remedies, cGMP

FDA Warns Mylan Over Quality System Failures By Zachary Brennan - Published 11 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 3 April to Mylan Pharmaceuticals for its Nashik, India-based manufacturing site, which FDA said does not have a functioning quality system.

Categories: News, India, US, FDA, Drugs, Government affairs, Manufacturing

Tags: Mylan, ARVs, LMIC, HIV, Mylan India

A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers By Zachary Brennan - Published 06 April 2017

As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Government affairs, Manufacturing

Tags: Form 483, FDA inspection reports, API manufacturing

Industry Wants FDA to Hit the Brakes on Quality Metrics Program By Michael Mezher - Published 30 March 2017

The US Food and Drug Administration's (FDA) proposed quality metrics program is proving to be a bitter pill for the pharmaceutical industry to swallow.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Manufacturing, Quality

Tags: Quality Metrics

Democrats Propose Wide-Ranging Bill to Lower Drug Costs By Zachary Brennan - Published 30 March 2017

House and Senate Democrats late Wednesday offered up a host of new provisions to bring down the rising cost of pharmaceuticals, many of which have been publicly opposed by the pharmaceutical industry.

Categories: News, US, FDA, Government affairs, Manufacturing, Research and development

Tags: drug prices, Medicare drug negotiations, drug imports, drug exclusivity, FDA regulations

FDA Warns Singapore Ophthalmic Drug Manufacturing Site By Zachary Brennan - Published 28 March 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations.

Categories: News, US, FDA, Drugs, Manufacturing, Regulatory strategy

Tags: sterile eye wash, FDA warning letters

FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

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