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FDA Issues Form 483 for Lupin's Goa Facility By Michael Mezher - Published 28 April 2017

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

Categories: News, India, US, FDA, Generic drugs, Manufacturing

Tags: Form 483, Lupin

EMA Plots Workload Shift Ahead of UK Experts' Departures in 2019 By Zachary Brennan - Published 28 April 2017

With a meeting yesterday between the European Medicines Agency's (EMA) Management Board and heads of the National Competent Authorities (NCAs) of the EU/EEA member states, a discussion was initiated on how to share the work of evaluating and monitoring medicines without the UK's help.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: Brexit, EMA headquarters, EMA move

Regulatory Recon: FDA Approves Novartis' Rydapt for AML; Questions Raised Over UK Cancer Drugs Fund (28 April 2017) By Michael Mezher - Published 28 April 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: Criteria for New EMA Host Coming Saturday; Concerns Raised About Integrity of International Trials (27 April 2017) By Michael Mezher - Published 27 April 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

House and Senate Revive Bill Targeting Generic Drug Delays By Zachary Brennan - Published 27 April 2017

Leaders of the Senate and House Judiciary Committees, led by Sen. Patrick Leahy (D-VT), on Thursday re-introduced legislation to combat anticompetitive practices that can block the market entry of lower-cost generic drugs. 

Categories: News, US, FDA, Clinical, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: CREATES Act, generic drug delay, REMS, Leahy

FDA Approves First Treatment for a Form of Batten Disease By Zachary Brennan - Published 27 April 2017

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

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

Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin

European Regulatory Roundup: Dutch MEB Raises Concerns About use of ADHD Drug Ritalin in Adults (27 April 2017) By Nick Paul Taylor - Published 27 April 2017

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

Categories: News, Europe, EMA, Drugs, Veterinary products

Tags: European Regulatory Roundup, CVMP, MEB

Senate Committee Advances Gottlieb Nomination as FDA Commissioner By Zachary Brennan - Published 27 April 2017

The Senate Health, Education, Labor & Pensions (HELP) committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Gottlieb, Senate FDA, FDA commissioner

Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin; GSK CEO Walmsley Says Pharma is Top Priority (26 April 2017) By Michael Mezher - Published 26 April 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

Supreme Court Weighs Biosimilar Patent Dance By Zachary Brennan - Published 26 April 2017

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary.

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

Tags: Supreme Court, biosimilars, Novartis, Sandoz

House to Consider MDUFA Add-Ons By Michael Mezher - Published 26 April 2017

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package.

Categories: News, FDA, Medical Devices

Tags: User Fees, Reauthorization, Energy & Commerce

Senate HELP Committee Delays Vote on Gottlieb Nomination By Michael Mezher - Published 26 April 2017

Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA).

Categories: News, US, FDA

Tags: Scott Gottlieb, Nomination, FDA Commissioner, Senate HELP Committee

Asia Regulatory Roundup: Australia Scraps Target Date for Processing GMP Applications (25 April 2017) By Nick Paul Taylor - Published 25 April 2017

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

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

Tags: Asia regulatory roundup, GMP applications, stents, antimicrobial resistance

The Prescription Drug User Fee Act (PDUFA): A Primer By Valerie Fauvelle, MS, RAC, Meredith Brown-Tuttle, RAC, FRAPS - Published 25 April 2017

This article discusses key points and benefits of the Prescription Drug User Fee Act (PDUFA) for those filing a New Drug Application (NDA) and explains how PDUFA user fees have played an important role in expediting FDA's drug approval process.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Submission and registration

Tags: User Fees, Prescription Drug User Fee Act, PDUFA

FDA Warns Teva API Plant in China By Zachary Brennan - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China.

Categories: News, US, FDA, Active pharmaceutical ingredients, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: Teva, warning letter, FDA inspections

Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss; After Trial Failures OncoMed Cuts Half its Staff (25 April 2017) By Michael Mezher - Published 25 April 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

Generic Drug Industry Group Seeks FDA Regulation Changes By Zachary Brennan - Published 25 April 2017

The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce.

Categories: News, US, FDA, Generic drugs, Regulatory intelligence, Regulatory strategy

Tags: generic drug policy, AAM and FDA regulations, label changes for generics

Health Canada to go eCTD-only for Drug Applications By Michael Mezher - Published 25 April 2017

Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.

Categories: News, Canada, Health Canada, Drugs, Submission and registration

Tags: Electronic Common Technical Document, eCTD

FDA Warns 14 Companies for Selling Fake Cancer Treatments By Michael Mezher - Published 25 April 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to 14 US-based companies for selling dozens of unapproved cancer treatments online and through social media.

Categories: News, US, FDA

Tags: Warning Letters, Misbranded Drugs, Fake Cancer Treatments

Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 2017) By Michael Mezher - Published 24 April 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

Pharma Execs Seek Smooth and Quick Transition of EMA Headquarters Out of London By Zachary Brennan - Published 24 April 2017

With an eye to avoiding public health issues during a transition period, executives from Novartis, Pfizer, Eli Lilly, Amgen and other companies are calling on the European Council to decide on the new headquarters location of the European Medicines Agency (EMA) “as early on as possibly, preferably at its meeting in June.”

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

Tags: Brexit, EMA headquarters

FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray By Zachary Brennan - Published 24 April 2017

As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can revive those who have overdosed on opioids.

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

Tags: Narcan, opioid overdose, Narcan nasal spray, naloxone

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

FDA Issues Draft Guidance on Extending Expiration Dates for Doxycycline Stockpiles By Michael Mezher - Published 24 April 2017

In response to questions from state health officials, the US Food and Drug Administration (FDA) on Monday issued draft guidance detailing how state emergency health response stakeholders can extend the shelf life of stockpiled doxycycline.

Categories: News, US, FDA, Drugs

Tags: Doxycycline, Medical Countermeasures, MCM, Anthrax

Medical Product Communications: Industry Seeks to Reform FDA Draft Guidances By Zachary Brennan - Published 21 April 2017

With a flood of new comments, pharmaceutical, biotech and medical device companies are seeking changes to two draft guidances explaining the US Food and Drug Administration's (FDA) evolving policies on industry communications with payers and claims that adhere to a drug's label.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Labeling, Medical Devices

Tags: medical product communications, off-label promotion, payer communications