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Filtering on: "topics due diligence"

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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

FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars By Zachary Brennan - Published 03 January 2017

Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar.

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

Tags: clinical pharmacology data, biosimilars, reference products, FDA guidance

FDA Warns Wockhardt for Destroying CGMP Documents, Other Violations By Zachary Brennan - Published 03 January 2017

The beleaguered Indian drug manufacturer Wockhardt is in trouble again with the US Food and Drug Administration (FDA), this time for destroying current good manufacturing practice (CGMP) documents, among a list of other major violations.

Categories: News, Asia, FDA, Active pharmaceutical ingredients, Compliance, Crisis management, Drugs, Due Diligence, Manufacturing

Tags: warning letter, Wockhardt, CGMP

EMA to Launch Tailored Biosimilar Scientific Advice Pilot By Zachary Brennan - Published 16 December 2016

The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.

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

Tags: biosimilars, biosimilar scientific advice, biosimilar data

NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage By Zachary Brennan - Published 15 December 2016

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to new medical devices, diagnostics and other health-related technologies.

Categories: News, Europe, US, CDRH, NICE, Due Diligence, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: NICE, medical device insurer coverage, medical devices and approval

FDA Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format By Zachary Brennan - Published 29 November 2016

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: News, US, FDA, ICH, Biologics and biotechnology, Drugs, Due Diligence, Quality, Regulatory intelligence, Regulatory strategy, Research and development, Submission and registration

Tags: ICH guidance, PSUR, PAER, PADER, PBRER

FTC Plans Crackdown on Marketing Claims of OTC Homeopathic Drugs By Zachary Brennan - Published 15 November 2016

The Federal Trade Commission (FTC) on Tuesday announced a new enforcement policy that will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims.

Categories: News, US, FTC, Advertising and Promotion, Over the counter drugs, Due Diligence, Quality

Tags: drug marketing, OTC drugs, homeopathic drugs

EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report By Zachary Brennan - Published 15 November 2016

The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the Pediatric Regulation, ten years after its implementation.

Categories: News, Europe, EC, EMA, MHRA, Clinical, Compliance, Due Diligence, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Paediatric Regulation, PIPs, PIP cost to pharmaceutical industry

EMA Recommends Nine Drugs for Approval By Zachary Brennan - Published 11 November 2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it recommended nine medicines for approval at its meeting earlier this week, including four new treatments, three biosimilars and two generics.

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

Tags: EMA CHMP, marketing authorisation in EU, Gilead, Sanofi, Novo Nordisk

FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies By Zachary Brennan - Published 10 November 2016

The US Food and Drug Administration (FDA) on Thursday announced it is withdrawing a proposed rule from 2001 that would have required the public disclosure of summaries of safety and effectiveness data, in addition to other information, from pre-market clinical trials of gene therapies and transplanted non-human tissues to humans, known as xenotransplantation.

Categories: News, US, CBER, Biologics and biotechnology, Clinical, Crisis management, Due Diligence, Government affairs, Human cell and tissue, Preclinical, Research and development

Tags: gene therapy, xenotransplantation, BIO, Public Citizen

Device Reporting Requirements for Manufacturers: FDA Finalizes Guidance By Zachary Brennan - Published 07 November 2016

The US Food and Drug Administration (FDA) on Monday finalized guidance to help medical device manufacturers meet the reporting and recordkeeping requirements for adverse events and malfunctions.

Categories: News, US, FDA, Crisis management, Due Diligence, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: device adverse events, reports on medical device malfunctions, FDA and device adverse events

Ireland Looks to Host New EMA Headquarters Following Brexit By Zachary Brennan - Published 26 October 2016

Ireland’s Minister for Health Simon Harris has confirmed that Ireland will formally bid to host the European Medicines Agency (EMA) headquarters in the aftermath of Brexit.

Categories: News, Europe, EMA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: EMA headquarters, Brexit

Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016) By Nick Paul Taylor - Published 25 October 2016

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

Categories: News, Asia, CDSCO, CFDA, Clinical, Crisis management, Drugs, Due Diligence, Medical Devices

Tags: Asia Regulatory Roundup, data falsification, Indian medical device rules

FDA Adopts New Warning on Abuse and Dependence to Prescription Testosterone By Zachary Brennan - Published 25 October 2016

The labels for all prescription testosterone products will now include a new warning and an updated Abuse and Dependence section to include safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other anabolic androgenic steroids (AAS). 

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

Tags: testosterone, FDA warnings on steroids, body builders and steroids

EMA Sets Deadlines for 2016 Type I Variations By Zachary Brennan - Published 24 October 2016

The European Medicines Agency (EMA) on Monday said that marketing authorization holders (MAHs) need to submit any minor changes to drug marketing authorizations, also known as Type IAIN and Type IA variations, for 2016 by 30 November.

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

Tags: Type I variations, EMA deadlines

BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022 By Zachary Brennan - Published 20 October 2016

A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase.

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

Tags: biosimilar, BsUFA, Biosimilar User Fee Act, FDA user fees, BPD meeting