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Filtering on: "topics due diligence"

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European Regulatory Roundup: New Gateway for Parallel Consultations on Marketing Authorizations, HTAs (6 July 2017) By Nick Paul Taylor - Published 06 July 2017

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EUnetHTA, type II variations, ATMPs

Novo Nordisk Warns of Possible Cracks in Insulin Devices By Zachary Brennan - Published 05 July 2017

Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents.

Categories: News, Canada, US, Crisis management, Due Diligence, Medical Devices

Tags: Novo Nordisk, insulin pen, insulin device, NovoPen Echo, NovoPen 5

House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017 By Zachary Brennan - Published 27 June 2017

The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration.

Categories: News, US, FDA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: FDA FY 2018, FDA budget, FDA appropriations

WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

Qualification of Drug Development Tools: FDA Updates Process By Zachary Brennan - Published 08 June 2017

Thanks to the 21st Century Cures Act, there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which can include biomarkers, animal models and clinical outcome assessments.

Categories: News, US, CDER, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: DDT, drug development tools, biomarkers, clinical outcome assessments

EMA Plots New Ways to Help Small and Medium-Sized Pharma Firms By Zachary Brennan - Published 31 May 2017

The European Medicines Agency (EMA) on Wednesday published an action plan for the next three years to help small and medium-sized pharmaceutical companies.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: small- and medium-sized pharmaceutical companies, EMA on SMEs

Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation By Zachary Brennan - Published 16 May 2017

Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: 21st Century Cures Act, HHS budget, Trump budget cuts, OMB

EMA to Continue to Allow Patient Involvement in CHMP Meetings By Zachary Brennan - Published 08 May 2017

The European Medicines Agency (EMA) said Monday that it will continue to allow patients to offer viewpoints during the assessments of the benefits and risks of medicines before EMA’s Committee for Medicinal Products for Human Use (CHMP).

Categories: News, Europe, EMA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs

Tags: patient perspective, CHMP, benefits and risks of medicines

Biosimilars Forum Seeks More Clarity in FDA Draft Guidance on Biosimilar Interchangeability By Zachary Brennan - Published 04 May 2017

The nonprofit industry group Biosimilars Forum is calling on the US Food and Drug Administration (FDA) to clarify that a demonstration of interchangeability represents a distinct requirement for additional data compared to a demonstration of biosimilarity.

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

Tags: biosimilars, FDA draft guidance, Biosimilars Forum

FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs By Zachary Brennan - Published 24 April 2017

After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained.

Categories: News, US, FDA, Crisis management, Drugs, Due Diligence

Tags: sodium thiopental, execution drugs, FDA and state executions, misbranded drugs

Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees By Zachary Brennan - Published 14 April 2017

With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: user fee reauthorization, FDA user fees, drug review fees

FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation By Zachary Brennan - Published 13 April 2017

Although almost half of patients with cancer who are cured will have received radiation therapy as a component of their care, there is still a dearth of new therapies being developed in combination with radiation, officials from the US Food and Drug Administration (FDA) wrote in an article published this week.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: hematology and oncology, radiation therapy, cancer drugs

FDA Warns Abbott Device Manufacturing Plant in California By Zachary Brennan - Published 13 April 2017

The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.

Categories: News, US, FDA, Due Diligence, Medical Devices, Quality

Tags: warning letter, Abbott, St. Jude Medical, ICDs, CRT-Ds

FDA Warns Pfizer Clinical Investigator Over Chantix Study By Zachary Brennan - Published 05 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent in January to a clinical investigator working on a study of Pfizer’s nicotine addiction treatment Chantix (varenicline tartrate).

Categories: News, US, FDA, Clinical, Compliance, Drugs, Due Diligence

Tags: Chantix, Pfizer, clinical trial, warning letter

FDA’s Draft Biosimilar Interchangeability Guidance: Stakeholders Seek More Clarity By Zachary Brennan - Published 04 April 2017

As comments on the US Food and Drug Administration’s (FDA) draft guidance on biosimilar interchangeability begin to trickle in, stakeholders seem optimistic and appreciative of the agency’s draft though some suggest tweaks to FDA's recommendations for switching studies.

Categories: News, US, FDA, Biologics and biotechnology, Due Diligence, Government affairs, Submission and registration

Tags: interchangeable biosimilars, interchangeability, FDA draft guidance, comments on FDA guidance

FDA Drafts List of Class II Devices to be Exempt From Premarket Notification By Zachary Brennan - Published 13 March 2017

The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s.

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

Tags: Class II devices, 21st Century Cures, FD&C Act

Trump’s FDA Commissioner Choice Coming Soon By Zachary Brennan - Published 08 March 2017

Dr. Tom Price, secretary of the US Department of Health and Human Services, said in an interview this week that the new commissioner for the US Food and Drug Administration (FDA) and other health-related political appointees should be announced in the next week or so.

Categories: News, US, FDA, Due Diligence, Government affairs

Tags: FDA commissioner, Scott Gottlieb, Tom Price

Transparency Push: EMA to Revise Policy on Document Access By Zachary Brennan - Published 17 February 2017

The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Clinical, Drugs, Due Diligence, Government affairs

Tags: pharmaceutical data transparency, EMA transparency

GOP Sets June Deadline for Completing FDA User Fee Reauthorizations By Zachary Brennan - Published 06 February 2017

Republicans have set a deadline of June to complete the Congressional work on reauthorizing the US Food and Drug Administration’s (FDA) user fee programs.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Drugs, Due Diligence, Government affairs, Medical Devices, Research and development

Tags: FDA user fees, PDUFA, MDUFA, BsUFA, GDUFA, user fee reauthorization

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance By Zachary Brennan - Published 06 February 2017

The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward.

Categories: Compliance, Crisis management, Due Diligence, Ethics, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: "two out, one in," Trump regulatory policy, FDA regulations

FDA Staff Shortages May Get Worse With Trump’s Federal Hiring Freeze By Zachary Brennan - Published 25 January 2017

On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: hiring freeze, Trump, FDA staff shortage

Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo By Zachary Brennan - Published 24 January 2017

A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner spoke with Focus on Tuesday.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence

Tags: FDA commissioner, Gulfo, Trump and FDA

FTC Continues Crackdown on Pay-for-Delay Agreements By Zachary Brennan - Published 23 January 2017

The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements that often keep generic drugs from entering the US market.

Categories: News, US, FTC, Generic drugs, Due Diligence, Government affairs, Regulatory strategy

Tags: pay-for-delay settlements, Endo, Allergan, Watson Laboratories, Impax

US Supreme Court to Review Biosimilar ‘Patent Dance’ By Zachary Brennan - Published 13 January 2017

The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Due Diligence, Government affairs

Tags: SCOTUS, John Roberts, biosimilar patent dance, biosimilars and SCOTUS

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs