Search Results for Inspections

Showing 1 – 25  of 80

FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities By Sharry Arora - Published 14 July 2017

The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs).

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

Tags: Oral Solid Dosage, OSD, Inspections

FDA Launches New ORA Structure to Align Inspections With Expertise By Michael Mezher - Published 15 May 2017

The US Food and Drug Administration (FDA) on Monday released details on the structure of its newly realigned Office of Regulatory Affairs (ORA).

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Program Alignment, Office of Regulatory Affairs, Inspections

European Regulatory Roundup: EMA Issues Increasing Number of GMP Non-Compliance Statements in India (11 May 2017) By Nick Paul Taylor - Published 11 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European regulatory roundup, PRAC, GMP inspections, flu vaccine guidance

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

House Committee Considers Four Device Bills to Add to User Fee Reauthorization By Zachary Brennan - Published 02 May 2017

The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites.

Categories: News, US, CDRH, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: medical device inspections, FDA inspections, hearing aids, OTC hearing aids, MITA, AdvaMed, contrast agents

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

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

AdvaMed CEO Confident of Device Tax Repeal This Year By Michael Mezher - Published 11 April 2017

The Advanced Medical Technology Association's (AdvaMed) President and CEO Scott Whitaker said Tuesday he's confident that the medical device tax introduced under the Affordable Care Act will be repealed this year.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: AdvaMed, Medical Device Tax, Inspections

FDA Office of Regulatory Affairs Realignment to Begin in May By Michael Mezher - Published 28 March 2017

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: News, US, FDA, Compliance, Medical Devices

Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce

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

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

Senators Look to Overhaul Medical Device Inspections By Michael Mezher - Published 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

Categories: News, US, CDRH, Government affairs, Medical Devices

Tags: Inspections

EMA Outlines GCP Inspection Plan for 2017 By Zachary Brennan - Published 21 February 2017

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GCP guidelines, GCP inspections, trial site inspections

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

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

Japan Joins International API Manufacturing Inspection Program By Zachary Brennan - Published 15 December 2016

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs).

Categories: News, Asia, Europe, US, EMA, FDA, PMDA, Active pharmaceutical ingredients, Manufacturing

Tags: ICH Q7, API manufacturing inspections

Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016) By Nick Paul Taylor - Published 06 December 2016

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

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

Tags: GMP pharmaceutical manufacturing, Chinese drug inspections, DTAB, Sugam, Asia Regulatory Roundup

FDA Calls on Pharma Companies to Join Manufacturing Inspection Program By Zachary Brennan - Published 15 November 2016

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday announced the launch of the 2017 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program, which is meant to help OPQ staff learn more about industry’s drug development and manufacturing processes.

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

Tags: OPQ inspections, FDA inspection training, CDER inspections

US, EU Look to Mutually Recognize GMP Inspections by January 2017 By Zachary Brennan - Published 26 October 2016

The US and EU say they have made more progress on harmonizing good manufacturing practice (GMP) inspections and could reach a deal by January 2017, according to a report on the 15th round of negotiations for the Transatlantic Trade and Investment Partnership (TTIP).

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

Tags: GMP inspections, regulatory harmonization, UDIs, quality inspections

FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation By Zachary Brennan - Published 24 October 2016

The US Food and Drug Administration (FDA) on Monday released a summary of hospital inspection findings, as well as Form 483s for 15 hospitals, detailing the hospitals' failures to report medical device-related adverse events in a timely manner.

Categories: News, US, CDRH, Government affairs, In vitro diagnostics, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: medical device adverse events, FDA inspections of hospitals, patient deaths from medical devices

FDA Warns Japanese Company for Impeding Inspection By Michael Mezher - Published 06 October 2016

The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

Categories: News, Asia, US, FDA, MHLW, PMDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs

Tags: warning letters, Nippon Fine Chemical, FDA inspections

EU, Japan to Share More Information on GMP Inspections By Zachary Brennan - Published 05 October 2016

The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan.

Categories: News, Japan, Europe, EMA, MHLW, PMDA, Government affairs, Manufacturing

Tags: mutual recognition of GMP inspections, EMA and PMDA, Pharmacopoeia

Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016) By Nick Paul Taylor - Published 04 October 2016

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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Australia drug manufacturing inspections, China medical devices

Surviving Your First FSMA Inspection By Joseph A. Levitt, Maile Gradison Hermida, Elizabeth Barr Fawell - Published 01 September 2016

This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices.

Categories: Features, US, FDA, Manufacturing, Nutritional and dietary supplements

Tags: FSMA, Food Safety Modernization Act, Inspections