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Filtering on: "topics compliance"

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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

When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains By Zachary Brennan - Published 12 December 2017

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: refuse to file, NDA, BLA, FDA draft guidance

Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017) By Nick Paul Taylor - Published 12 December 2017

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

Categories: News, Asia, Oceania, TGA, Compliance, Drugs, Government affairs

Tags: Asia Regulatory Roundup, ACSS, GSK, Novartis

FDA Warns California Device Company for Failing to Disclose Serious Injury By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last month to Sacramento, California-based Hand Biomechanics Lab after the firm failed to submit a report to the agency of a serious injury that may have been caused by one of the company’s medical devices.

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

Tags: warning letter, device injury

Woodcock: CDER Informatics System is Top Priority for 2018 By Michael Mezher - Published 05 December 2017

Going into 2018, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that her top priority will be to implement a center-wide informatics system.

Categories: News, US, CDER, Biologics and biotechnology, Compliance, Generic drugs, Over the counter drugs, Prescription drugs, Submission and registration

Tags: 21st Century Cures, Informatics, CDER

FDA Finalizes Chagas Disease Guidance for Blood Collection Establishments By Zachary Brennan - Published 05 December 2017

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on the use of serological tests to reduce the risk of transmission of T. cruzi, a parasite that causes Chagas Disease, in blood and blood components.

Categories: News, US, CBER, Blood, Compliance

Tags: Chagas Disease, blood collection, FDA guidance

OPDP Issues Third Warning of 2017 By Zachary Brennan - Published 28 November 2017

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate).

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

Tags: untitled letter, warning letter, OPDP

FDA Warns, Blocks Imports From Chinese API Manufacturer By Zachary Brennan - Published 27 November 2017

Earlier this month, the US Food and Drug Administration (FDA) sent a warning letter to a Hubei, China-based active pharmaceutical ingredient (API) manufacturer related to several failures.

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

Tags: FDA warning letter

Administering the Hatch-Waxman Amendments: Industry, Academics and Senator Discuss Balance By Zachary Brennan - Published 27 November 2017

The US Food and Drug Administration (FDA) has made it a priority to find a balance between encouraging innovative medical products and increasing access to lower-cost pharmaceuticals under the Hatch-Waxman Act 1984. But when it comes to finding ways to speed the influx of generic drugs and stop frequently cited abuses, a host of voices from industry, academia and Congress are offering differing views.

Categories: News, US, FDA, Compliance, Drugs, Government affairs, Labeling

Tags: Hatch-Waxman, generic drug competition, CREATES Act

Advances in Sequencing Likely to Shift Paradigm in Cancer Drug Approvals, FDA Experts Say By Zachary Brennan - Published 07 November 2017

Experts within FDA's newly established Oncology Center of Excellence (OCE) discussed the office's role in the first site-agnostic cancer treatment approval and programs for further advancing oncology-related regulatory science and policy.

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

Tags: DNA sequencing, Oncology Center of Excellence, biomarker, OS

Reps Question Gottlieb on Bayer's Follow-Up Essure Studies By Zachary Brennan - Published 31 October 2017

Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure.

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

Tags: Essure, Bayer, Gottlieb, medical device safety

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

FDA Offers Two Draft Guidances on Drug-Drug Interactions By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs).

Categories: News, US, FDA, Compliance, Drugs, Research and development

Tags: drug-drug interactions, FDA draft guidance, in vitro metabolism

ISO: Identification of Medicinal Products Standards Revised By Zachary Brennan - Published 23 October 2017

The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information.

Categories: News, Canada, Europe, US, ISO, Compliance, Drugs, Government affairs

Tags: IDMP standards

FDA Warns Swedish IVD Manufacturer By Zachary Brennan - Published 10 October 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 20 September to Malmo, Sweden-based Euro Diagnostica AB, which manufactures multiple class II in vitro diagnostic (IVD) devices.

Categories: News, Europe, US, CDRH, Compliance, Due Diligence, In vitro diagnostics, Medical Devices, Quality

Tags: FDA warning letters, IVD manufacturer warning letter, Euro Diagnostica

HHS Inspector General Finds FDA Spends User Fees Appropriately By Zachary Brennan - Published 05 October 2017

The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately.

Categories: News, US, FDA, Compliance, Drugs, Government affairs

Tags: HHS OIG, user fee expenses, prescription drug user fees

FDA Targets Complex Generic Drugs With New Draft Guidance By Zachary Brennan - Published 02 October 2017

The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Submission and registration

Tags: generic drugs, complex generic drugs, FDA draft guidance

FDA Warns Chinese Drugmaker Over Fake Test Results, Blocking Access to Inspectors By Michael Mezher - Published 26 September 2017

The US Food and Drug Administration (FDA) has warned Chinese drugmaker Shandong Vianor Biotech for violating good manufacturing practice (GMP) requirements following an inspection of the firm's Linyi, Shandong facility last May.

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

Tags: Good Manufacturing Practice, GMP, Warning Letter

Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017) By Nick Paul Taylor - Published 26 September 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup, Pakistan

Mistake-Proofing the Workplace By Zachary Sherman, Max Sherman - Published 22 September 2017

This article discusses mistakes, or human errors, made in the pharmaceutical or medical device workplace and provides the definition of a mistake. The authors also present how mistakes are made, whether such errors are the actual "root cause" of defects, the social and company consequences of errors, and what can be done to minimize errors.

Categories: Features, Compliance, Manufacturing, Quality

Tags: Errors, Defects, Quality

Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars By Zachary Brennan - Published 20 September 2017

Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance on the US market for its blockbuster Remicade (infliximab) despite recently introduced competition.

Categories: News, US, FDA, Biologics and biotechnology, Compliance

Tags: Pfizer, J&J, infliximab, Remicade, Inflectra, Renflexis

Balancing Hatch-Waxman: Stakeholders Weigh in After FDA’s Meeting By Zachary Brennan - Published 20 September 2017

Following a US Food and Drug Administration (FDA) meeting in July on generic drug competition, various stakeholders are offering written comments on reforms FDA and Congress could make to ensure the Hatch-Waxman amendments are not abused.

Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: REMS, Hatch-Waxman, generic drug competition

House Reps Seek More Transparency on Novartis-CMS Pricing Deal for Newly Approved CAR-T Therapy By Zachary Brennan - Published 14 September 2017

Rep. Lloyd Doggett (D-TX) and other House Democrats on Wednesday sent a letter to Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), seeking to find out more information about an outcomes-based payment approach for Novartis’ newly approved chimeric antigen receptor T-cell (CAR-T) treatment Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

Categories: News, US, Compliance, Reimbursement

Tags: CAR-T, outcomes-based deal, Novartis

Procedures for Device Advisory Committee Meetings: FDA Finalizes Guidance By Zachary Brennan - Published 31 August 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Thursday finalized guidance from 2015 on advisory committee meetings.

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

Tags: medical device advisory committee meetings

FDA Aligns With Citizen Petition, Revises Draft Guidance on Pricey Generic Heart Drug By Zachary Brennan - Published 29 August 2017

Manufacturers looking to market generic versions of a heart medicine that has been around since the 18th century and seen its price rise by more than 600% in recent years will have to work with a new revised US Food and Drug Administration (FDA) draft guidance released Tuesday.

Categories: News, US, FDA, Compliance, Generic drugs

Tags: digoxin, generic draft guidance, Concordia Pharmaceuticals