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Filtering on: "topics manufacturing"

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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

BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics By Michael Mezher - Published 15 March 2017

The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics.

Categories: News, US, FDA, Biologics and biotechnology, Manufacturing, Packaging

Tags: Mixing, Diluting, Repackaging, Compounding, Outsourcing Facilities, BIO, Pew

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

Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 By Zachary Brennan - Published 08 March 2017

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, Drugs, Government affairs, Manufacturing

Tags: PIC/S, GMP guidelines, regulatory affairs

FDA Warns Wockhardt Subsidiary, Says Seven of Company's Facilities Out of Compliance By Michael Mezher - Published 08 March 2017

The US Food and Drug Administration (FDA) has warned Wockhardt subsidiary Morton Grove Pharmaceuticals over quality control and data integrity issues.

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

Tags: Warning Letter, Data Integrity

CDER Goals for 2017: Improved Informatics, Cures Act Implementation and User Fees By Zachary Brennan - Published 07 March 2017

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock outlined the critical priorities for 2017 in a new podcast as part of what she said will be "another busy and productive year."

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Woodcock, CDER, FDA priorities, Cures, user fee bills

Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017) By Nick Paul Taylor - Published 07 March 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, TGA inspections, NPPA

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’s Woodcock to Congress: Pass the GDUFA and BsUFA Reauthorizations By Zachary Brennan - Published 02 March 2017

Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, was in the hot seat on Thursday taking questions from the House Energy & Commerce Committee and urging the representatives to pass reauthorizations of the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BsUFA).

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

Tags: GDUFA, BsUFA, Woodcock, FDA user fees

US and EU Forge Landmark Agreement to Mutually Recognize Drug Manufacturing Inspections By Zachary Brennan - Published 02 March 2017

After wrangling over the details of trade secrets and inspection differences, the US and EU on Thursday finally announced they have agreed to mutually recognize one another’s pharmaceutical manufacturing inspections – a deal likely to lead to less duplicative inspections and lower costs on both sides of the Atlantic.

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

Tags: GMP inspections, EMA and FDA initiatives, mutual recognition agreements, US-EU international agreement

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

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 2017

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

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

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

CDRH and CDER Send Warning Letters to Six Asian Companies By Zachary Brennan - Published 14 February 2017

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: warning letters, China drug manufacturing, India drug manufacturing

CDRH Warns Three Foreign Medical Device Manufacturers By Zachary Brennan - Published 07 February 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday released three warning letters sent to medical device manufacturers in Taiwan, China and South Korea.

Categories: News, US, CDRH, Compliance, Manufacturing, Medical Devices

Tags: warning letters, quality data

Challenges Surrounding the Development and Manufacturing of ATMPs Continue By Zachary Brennan - Published 03 February 2017

The experience of conducting clinical trials with advanced therapy medicinal products (ATMPs) in a real-world clinical setting, according to a new European Medicines Agency (EMA) summary of a conference discussion, can mean “battling multiple and often ridiculous barriers.”

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Blood, Combination products, Manufacturing

Tags: ATMPs, EMA conferences

Italian Medicines Agency Cites Brazilian Drugmaker for GMP Violations By Michael Mezher - Published 31 January 2017

The Italian Medicines Agency (AIFA) has banned the supply of certain drugs made by Antibioticos do Brasil (ABL) following an inspection of the company's San Paulo, Brazil facility in December.

Categories: News, Europe, Latin America and Caribbean, Drugs, Manufacturing, Quality

Tags: AIFA, Italian Medicines Agency, Antibioticos do Brasil, ABL

FDA Warns UK Drugmaker for Repeat GMP Violations By Michael Mezher - Published 25 January 2017

The US Food and Drug Administration (FDA) has warned UK-government owned Porton Biopharma Limited for repeat good manufacturing practice (GMP) violations at its Salisbury, UK facility.

Categories: News, Europe, US, FDA, Biologics and biotechnology, Compliance, Manufacturing, Quality

Tags: Porton Biopharma, Jazz Pharmaceuticals, Erwinaze

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

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

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

Tags: Warning Letter, Data Integrity, Import Alert

Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown By Zachary Brennan - Published 18 January 2017

A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety.

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

Tags: foreign pharmaceutical inspections, FDA foreign offices, FDA in China, FDA and India

FDA and MHRA Break Down Foreign Inspection Data By Zachary Brennan - Published 11 January 2017

Both the US Food and Drug Administration (FDA) and the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) are slowly ramping up their inspections of foreign manufacturers, according to the latest statistics.

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

Tags: foreign drug inspections, foreign device inspections

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

Submitting Manufacturing Establishment Info Electronically: FDA Offers Draft Guidance By Zachary Brennan - Published 03 January 2017

Pharmaceutical manufacturers take note: The days of non-electronic submissions of establishment information are coming to an end, possibly as soon as 2019.

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

Tags: pharmaceutical manufacturing, draft guidance, manufacturing information

Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017) By Nick Paul Taylor - Published 03 January 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, CFDA guidance, generic drug inspections, codeine

2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning By Zachary Brennan - Published 20 December 2016

Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June).

Categories: News, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Labeling, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical regulations, year in review, Cures, Trump