Search Results for Zachary Brennan

Showing 1 – 25  of 509

Brexit Conundrum: How Does MHRA Work With EMA Moving Forward By Zachary Brennan - Published 24 June 2016

With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.

Categories: News, Europe, EC, EMA, MHRA, NICE, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Brexit, UK regulation of medicines, regulation of drugs after Brexit

Quality Metrics: FDA Outlines What Data to Submit By Zachary Brennan - Published 24 June 2016

The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.

Categories: News, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Due Diligence, Government affairs, Manufacturing

Tags: FDA quality metrics, OPQ, drug quality

BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years By Zachary Brennan - Published 23 June 2016

Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years.

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

Tags: biologics exclusivity, biosimilars, BPCIA, market exclusivity

Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed By Zachary Brennan - Published 23 June 2016

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

Categories: News, Africa, WHO, Biologics and biotechnology, Government affairs, Project management, Regulatory intelligence, Submission and registration

Tags: Gavi, PATH, malaria vaccine, GSK, Gates Foundation

New Report Calls on FDA to Clarify Use of Real-World Evidence By Zachary Brennan - Published 23 June 2016

As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments.

Categories: News, US, FDA, Clinical, Drugs, Government affairs, Medical Devices, Postmarket surveillance, Product withdrawl and retirement

Tags: real world evidence, FDA Commissioner, Robert Califf, Patrick Soon-Shiong, Duke University

Obama Signs Chemical Safety Bill Into Law By Zachary Brennan - Published 22 June 2016

President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US.

Categories: News, US, Crisis management, Manufacturing, Quality

Tags: TSCA, chemical safety, new chemicals law

FDA Pilot Project to Test New Import Communication System By Zachary Brennan - Published 22 June 2016

The Food and Drug Administration (FDA) on Wednesday said it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) and is seeking participants.

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

Tags: ITACS, ACE, imports and FDA

FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics By Zachary Brennan - Published 22 June 2016

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory intelligence, Regulatory strategy

Tags: ISCRs, ICH, eCTD, E2B(R3)

FDA Warns Medtronic Subsidiary Over Adulterated Devices By Zachary Brennan - Published 22 June 2016

Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx.

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

Tags: Medtronic, absorbable mesh, antibacterial envelope, device warning letter

EMA and FDA Begin Collaborations on Patient Engagement By Zachary Brennan - Published 22 June 2016

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines.

Categories: News, Europe, US, FDA, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA cluster, patient engagement, drug regulators working with patients

FDA Warns Questionable Cancer Clinic Again for CGMP Violations By Zachary Brennan - Published 21 June 2016

A little more than a month after the US Food and Drug Administration (FDA) was overruled by a judge to allow a college student with terminal cancer to re-start a clinical trial, in which he’s the only patient, FDA has issued a warning letter to the manufacturing facility linked to the trial, noting serious current good manufacturing practice (CGMP) violations.

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

Tags: Burzynski, antineoplastons, warning letter

Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses By Zachary Brennan - Published 21 June 2016

The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market.

Categories: News, US, FDA, Drugs

Tags: CREATES Act, REMS, Senate Judiciary

FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes By Zachary Brennan - Published 21 June 2016

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for new biosimilars.

Categories: News, US, FDA, Biologics and biotechnology, Government affairs, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: biosimilar names, biosimilar suffixes

Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions By Zachary Brennan - Published 20 June 2016

Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Government affairs, Quality, Research and development

Tags: biosimilars, interchangeability, BPCIA

FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices By Zachary Brennan - Published 20 June 2016

A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling.

Categories: News, US, CDRH, Clinical, Medical Devices, Regulatory intelligence, Regulatory strategy, Research and development

Tags: pediatric medical devices, medical device clinical data

Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds By Zachary Brennan - Published 20 June 2016

For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Due Diligence, Government affairs, Postmarket surveillance, Quality, Research and development

Tags: biosimilars, EU uptake of biosimilar medicinal products, IMS Health, EPO, Anti-TNF, Humira, Enbrel, Remicade

EC Seeks to Update Scientific Opinions on Non-Human Primate Research, Safety of Breast Implants By Zachary Brennan - Published 17 June 2016

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) on Friday announced that it’s seeking more information to update its scientific opinions on the need for non-human primate research, production and testing of drugs and devices, and whether to update its opinion on the safety of PIP breast implants and the possible link between breast implants and a rare cancer.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Drugs, Due Diligence, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance

Tags: EC's SCHEER, non-human primate biomedical research, PIP breast implants, breast implants and cancer

Device Clinical Studies: FDA Outlines How to Evaluate and Report Age, Race and Ethnic Group Data By Zachary Brennan - Published 17 June 2016

The US Food and Drug Administration (FDA) on Friday released new draft guidance intended to help improve the quality, consistency and transparency of clinical data on the performance of devices for particular patients in various age, race and ethnic groups.

Categories: News, US, CDRH, Clinical, Labeling, Medical Devices, Postmarket surveillance, Preclinical

Tags: medical device clinical trials, device trial populations, clinical trial enrollment

EMA Tries to Assuage Professors on Assumptions Linked to Adaptive Pathways Pilot By Zachary Brennan - Published 17 June 2016

The European Medicines Agency’s (EMA) Executive Director Guido Rasi and senior medical officer Hans-Georg Eichler sent a letter on Thursday to clarify some assumptions called into question by a group of nine professors who are criticizing aspects of the agency’s adaptive pathways pilot program.

Categories: News, Europe, EMA, Compliance, Drugs, Government affairs, Postmarket surveillance, Research and development

Tags: adaptive pathways, Oxford, Cambridge, fast-track, Bluebird Bio

FDA Offers New Draft Guidance on Bioequivalence Studies for 19 Generics, 19 Revisions By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday released 38 new and revised draft guidance documents for drugmakers looking to begin research and development for new generics, including for some blockbuster drugs that have not yet lost patent protection.

Categories: News, US, FDA, Compliance, Generic drugs, Due Diligence, Government affairs, Research and development

Tags: Viekra Pak, Eli Lilly, AstraZeneca, generic drug draft guidance, generic drug development

Two Indian Contract Pharma, API Manufacturers Refuse FDA Inspections By Zachary Brennan - Published 16 June 2016

The US Food and Drug Administration (FDA) this week added contract manufacturer Cheryl Laboratories’ Navi Mumbai-based manufacturing facility and active pharmaceutical ingredient (API) and intermediate manufacturer Phalanx Labs’ Visakhapatnam-based site to its list of foreign firms that are banned from shipping product to the US because they refused FDA inspections.

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

Tags: API manufacturing, FDA manufacturing inspections

New Senate Bill Aims to Close Regulatory Loopholes Blocking Generic Drug Competition By Zachary Brennan - Published 15 June 2016

Members of the Senate Judiciary Committee introduced bipartisan legislation on Tuesday that seeks to stop anticompetitive practices brand name drug companies often use to thwart or delay the entry of less-expensive generic versions of their products.

Categories: News, US, DOJ, FDA, FTC, Business and Leadership, Crisis management, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug competition, CREATES Act, REMS

GAO Offers Sharp Critique of FDA’s Lack of Measurable Regulatory Science Goals By Zachary Brennan - Published 15 June 2016

The Government Accountability Office (GAO) on Wednesday released two reports criticizing the Food and Drug Administration (FDA), one that says FDA lacks measurable goals to assess its progress in advancing regulatory science, and another that says FDA should better coordinate between its medical product centers.

Categories: News, US, FDA, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: GAO on FDA, regulatory science, FDA center communications

Former FDA Deputy Director Charged With Insider Trading for Leaking Non-Public Approval Information By Zachary Brennan - Published 15 June 2016

A former Deputy Director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) was charged on Wednesday for providing tips on drug approvals to three hedge fund managers that made tens of millions off of the non-public information.

Categories: News, US, CDER, Clinical, Crisis management, Drugs

Tags: FDA, OGD, insider trading, FDA non-public information, securities trading with non-public information

EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations By Zachary Brennan - Published 15 June 2016

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Government affairs, Medical Devices, Quality

Tags: medical device and IVDs in EU, new device regulations, European Commission medical device regulations