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Filtering on: "topics manufacturing"

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Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance By Michael Mezher - Published 18 January 2018

The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight.

Categories: News, US, FDA, Manufacturing

Tags: Compounding, Outsourcing Facilities, cGMP, Good Manufacturing Practice, Drug Quality and Security Act, DQSA

FDA Warns 5 Drugmakers in China, Australia and Austria By Zachary Brennan - Published 18 January 2018

The five warning letters sent from the US Food and Drug Administration (FDA) in December and January deal with violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients (APIs).

Categories: News, US, CDER, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing

Tags: warning letter, cGMP violations

FDA Warns Imprimis for False and Misleading Website and Twitter Promotions By Zachary Brennan - Published 16 January 2018

The US Food and Drug Administration (FDA) late last month sent a warning letter to San Diego-based Imprimis Pharmaceuticals for false and misleading claims made on the company’s website and Twitter account, among other violations.

Categories: News, US, FDA, Advertising and Promotion, Compliance, Drugs, Government affairs, Manufacturing

Tags: Imprimis, Twitter, FDA warning letters

FDA Details New Manufacturing Quality Pilot Program By Michael Mezher - Published 15 January 2018

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.

Categories: News, US, FDA, Manufacturing, Medical Devices, Quality

Tags: Case for Quality, Pilot

FDA Warns Fresenius Kabi API Manufacturing Plant By Zachary Brennan - Published 02 January 2018

The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi’s active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing

Tags: Fresenius, warning letter, API manufacturing

CMC Changes for Biologics: FDA Offers Draft Guidance By Zachary Brennan - Published 21 December 2017

The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA).

Categories: News, US, CBER, Biologics and biotechnology, Manufacturing

Tags: FDA draft guidance, CMC changes

European Commission Consults on Revised GMPs for Sterile Drugs By Michael Mezher - Published 20 December 2017

The European Commission on Wednesday launched a three-month public consultation ahead of its planned revision to good manufacturing practice (GMP) rules for sterile medicinal products contained in Annex 1 of Eudralex Volume 4.

Categories: News, Europe, EC, Drugs, Manufacturing

Tags: Eudralex Volume 4, Annex 1, Sterile Drugs, Good Manufacturing Practice, GMP

UK's MHRA: Apotex Site Does Not Comply With GMP Requirements By Zachary Brennan - Published 18 December 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant.

Categories: News, Asia, Europe, MHRA, Compliance, Crisis management, Due Diligence, Manufacturing

Tags: GMP requirements, Apotex, statement of noncompliance

Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics By Michael Mezher - Published 18 December 2017

The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Manufacturing, Preclinical

Tags: Nanomaterials, Nanotechnology, Draft Guidance

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish.

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

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

3D Printing: FDA Finalizes Guidance for Medical Devices By Michael Mezher - Published 04 December 2017

The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

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

Tags: 3D Printing, Additive Manufacturing, Final Guidance

Third Party Certification for Drugs Associated With an Import Alert Exception By Allyn R. Becker, PhD, Mark Lookabaugh - Published 24 November 2017

The US Food and Drug Administration (FDA) has begun a widely recognized campaign of intensified surveillance of foreign manufacturers of Active Pharmaceutical Ingredients (APIs) and finished drug products. Failure to comply with the regulatory requirements for good manufacturing practice can subject a foreign firm to an import alert, thereby cutting off access to commercial distribution in the US. This article provides an overview of the consequences of an import alert and the steps that may be required to have an alert lifted by FDA.

Categories: Features, US, FDA, Active pharmaceutical ingredients, Distribution, Drugs, Manufacturing

Tags: Third Party Certification, Import Alert

Lupin Warned by FDA for Deficiencies at Two Facilities By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India.

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

Tags: Warning Letter, GMP, Lupin, Goa, Indore

TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices By Michael Mezher - Published 09 November 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.

Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration

Tags: 3D-Printing, Custom Medical Devices

FDA Warns Chinese Firm for Confusing API in OTC Drug By Zachary Brennan - Published 07 November 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs made the firm was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate.

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

Tags: hydrocortisone, China API manufacturing, FDA warning letter

FDA Revises Priority ANDA Draft Guidance By Michael Mezher - Published 03 November 2017

The US Food and Drug Administration (FDA) on Friday issued a revised version of its draft guidance on the information that must be pre-submitted in order to receive a priority review for an abbreviated new drug application (ANDA).

Categories: News, US, FDA, Generic drugs, Manufacturing, Submission and registration

Tags: Priority ANDAs, GDUFA II, Pre-Submission Facility Correspondence, PFC

FDA to Recognize 8 EU Regulators to Conduct GMP Inspections By Zachary Brennan - Published 31 October 2017

The US Food and Drug Administration (FDA) on Tuesday announced that beginning on Wednesday, the agency will recognize eight EU drug regulators – from Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – as capable of conducting inspections of manufacturing facilities that meet FDA requirements.

Categories: News, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Manufacturing

Tags: FDA and EMA mutual recognition, GMP inspections, MRA

FDA Warns Canadian, Indian Drugmakers By Zachary Brennan - Published 31 October 2017

The US Food and Drug Administration (FDA) on Tuesday released two warning letters sent to Burlington, Ontario-based Aztex Enterprises and Raigad, India-based Kim Chemicals Private Ltd.

Categories: News, US, FDA, Drugs, Manufacturing

Tags: warning letters

Merck: Cyberattack Caused $135M in Lost Sales By Michael Mezher - Published 27 October 2017

In its third quarter earnings report, US pharmaceutical company Merck said that manufacturing disruptions tied to a cyberattack last June led to $135 million in lost sales and caused the company to borrow from a US Centers for Disease Control's (CDC) strategic stockpile to meet demand for one of its vaccines.

Categories: News, US, Biologics and biotechnology, Manufacturing

Tags: Cybersecurity, Merck, Cyberattack, Petya, Gardasil 9

FDA Warns Three Device Companies From US, Germany and France, One Indian API Manufacturer By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) this week released three warning letters sent to medical device manufacturers, including Florida-based UVLrx Therapeutics, Inc., Germany-based DRG Instruments GmbH and France-based ELITech Group SAS, as well as one to Vapi, India-based active pharmaceutical ingredient (API) manufacturer Vital Laboratories.

Categories: News, Asia, Europe, US, FDA, Active pharmaceutical ingredients, Compliance, Manufacturing, Medical Devices

Tags: warning letters, ELISA, CAPA

Updated FDA Manual Offers Inside Look at Inspection Protocols By Zachary Brennan - Published 18 October 2017

The US Food and Drug Administration (FDA) earlier this week published its 2017 version of a chapter of its investigations operations manual on establishment inspections, offering an inside look at how inspections are conducted and what companies should expect.

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

Tags: FDA inspections, contamination, sterile environments

Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports By Zachary Brennan - Published 16 October 2017

Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes to be documented in annual reports.

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

Tags: CMC changes, BIO, Sanofi, Pfizer, GSK, AAM

European Commission Adopts Two Acts on GMPs for Medicines By Zachary Brennan - Published 10 October 2017

Last month, the European Commission adopted two legal acts seeking to improve patient safety through good manufacturing practices (GMP) that ensure the highest quality of medicines for investigational and human use.

Categories: News, Europe, EC, Biologics and biotechnology, Drugs, Manufacturing

Tags: good manufacturing practices, implementing directive, delegated regulation, GMPs for investigational medicines

Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Manufacturing

Tags: continuous manufacturing, Pfizer, AAM, Vertex, AstraZeneca

FDA Warns Korean Drugmaker Over Testing, GMP Issues By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January.

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

Tags: Warning Letter, GMP