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Filtering on: "topics regulatory intelligence"

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Regulatory Recon: PhRMA CEO Says FDA Review Process Should Remain the 'Gold Standard'; BMS Takeover Rumors Rise After Icahn Buys Stake (22 February 2017) By Michael Mezher - Published 22 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Amphastar Hit With CRL for Intranasal Nalaxone; NICE Rejects Ipsen's Cabometyx in Draft Guideline (21 February 2017) By Michael Mezher - Published 21 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA Outlines GCP Inspection Plan for 2017 By Zachary Brennan - Published 21 February 2017

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GCP guidelines, GCP inspections, trial site inspections

Sarepta Sells Priority Review Voucher for $125M to Gilead By Zachary Brennan - Published 21 February 2017

Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

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

Tags: Sarepta, Gilead, priority review voucher, PRV, Cures

Regulatory Recon: FDA Warns Pfizer's Kansas Site; AstraZeneca Sells Zoladex Rights for $250M (20 February 2017) By Michael Mezher - Published 20 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar By Zachary Brennan - Published 20 February 2017

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: News, US, FDA, Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration

Tags: Genentech, Roche, Avastin, Amgen, biosimilars

Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations (17 February 2017) By Michael Mezher - Published 17 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule By Zachary Brennan - Published 16 February 2017

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

Categories: News, US, FDA, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: PhRMA, BIO, intended use, Allergan, rulemakings

House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal By Zachary Brennan - Published 16 February 2017

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

Categories: US, FDA, Drugs, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: DeLauro, mandatory drug recall, FDA authority, drug recalls, homeopathic

Regulatory Recon: Broad Triumphs in CRISPR Patent Dispute; FDA Approves Valeant Psoriasis Drug Siliq (16 February 2017) By Michael Mezher - Published 16 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Merck's Lead Alzheimer's Candidate Fails in Late Stage Study; EU Ready for First Cancer Biosimilars (15 February 2017) By Michael Mezher - Published 15 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars By Zachary Brennan - Published 15 February 2017

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

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

Tags: biosimilars, nonproprietary names for biosimilars, nonproprietary names for biologics, FDA guidance

CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions By Yingying Liu, Siegfried Schmitt - Published 15 February 2017

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Features, China, CFDA, FDA, WHO, Government affairs, Regulatory intelligence

Tags: Chinese Center of Food and Drug Inspection, CFDI

Regulatory Recon: Califf Speaks Out on Speeding Approvals, FDA Staffing; US Panel Backs CRISPR Use in Human Embryos to Avoid Serious Disease (14 February 2017) By Michael Mezher - Published 14 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: NICE Backs Incyte's Iclusig, Rejects AZ's Daxas; More Fallout From Marthon's Emflaza Pricing (13 February 2017) By Michael Mezher - Published 13 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

Regulatory Recon: Tom Price Confirmed as HHS Secretary; FDA Approves Marathon's Emflaza for DMD (10 February 2017) By Michael Mezher - Published 10 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Sen. Grassley Opens Inquiry Into Orphan Drug Act By Zachary Brennan - Published 10 February 2017

Sen. Charles Grassley (R-IA) on Friday confirmed to Focus that he is gathering more information and discussing with his staff and interested parties a possible inquiry into the Orphan Drug Act’s abuses leading to high drug prices.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Orphan Drug Act, Grassley, orphan drugs

Internal HHS Memo: Some FDA Employees Will be Exempt From Trump Hiring Freeze By Zachary Brennan - Published 09 February 2017

An internal memo from the Department of Health and Human Services (HHS) obtained by Focus on Thursday reveals that a number of positions at the US Food and Drug Administration (FDA), particularly within the Office of New Drugs, will likely be exempt from President Donald Trump’s federal hiring freeze.

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

Tags: employee freeze, HHS memo, FDA staffing, federal hiring freeze

Regulatory Recon: Court Clears Sanofi, Regeneron to Sell Praluent During Appeal; Xarelto Trial Stopped Early (9 February 2017) By Michael Mezher - Published 09 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Recon: Trump Backs Medicare Drug Price Negotiations; FDA Approves Amgen's Parsabiv After Rejection in August (8 February 2017) By Michael Mezher - Published 08 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

ICH Offers Updates on New Members, Progress on Guidelines By Zachary Brennan - Published 08 February 2017

The International Council on Harmonisation (ICH) has added new observers and members, as well as updates on different guidance documents discussed at its November meeting in Japan, according to meeting minutes released Wednesday.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, Middle East, US, ICH, Biologics and biotechnology, Compliance, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ANVISA, BIO, MFDS, CECMED, MCC, S11, GCP, regulatory guidance

FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics By Zachary Brennan - Published 07 February 2017

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which was first approved by FDA in 1986.

Categories: News, US, FTC, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Vancocin, c. difficile, Eli Lilly, Shire, citizen petitions

Regulatory Recon: Biotech Leaders Speak Out Against US Immigration Order; Teva CEO Resigns (7 February 2017) By Michael Mezher - Published 07 February 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017) By Nick Paul Taylor - Published 07 February 2017

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

Categories: News, Asia, CDSCO, CFDA, MFDS, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: India medical device regulations, DRAP, TFDA