Search Results for Zachary Brennan

Showing 1 – 25  of 1146

White House Doubles Down on Call to Fund FDA Entirely With Industry Fees By Zachary Brennan - Published 13 July 2017

Following the House of Represenatatives' passage of the bill to reauthorize US Food and Drug Administration (FDA) user fees on Wednesday, the White House doubled down on its earlier call to amend the agreements so that FDA is entirely funded by medical products industries.

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

Tags: White House, Donald Trump, FDA user fees, Right-to-Try, FDA bill

Regulatory Recon: FDA Rejects Drug Over Manufacturing Issues; Advisory Panel Backs Pfizer’s Mylotarg (12 July 2017) By Zachary Brennan - Published 12 July 2017

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

Categories: News, Europe, US, FDA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

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

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Opdivo, Keytruda, Yervoy, B-MS, Merck, uveitis

FDA Panel Votes Unanimously in Favor of First CAR-T Cancer Therapy By Zachary Brennan - Published 12 July 2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee on Wednesday voted unanimously, 10 to 0, in favor of the benefit-risk profile for the first of a new kind of cancer therapy, known as a Chimeric Antigen Receptor T-cell (CAR-T) therapy.

Categories: News, US, FDA, Government affairs, Human cell and tissue, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CAR-T, Novartis, CTL019, gene therapy, cell therapy, ODAC

House Passes Bill to Reauthorize FDA User Fee Programs By Zachary Brennan - Published 12 July 2017

In a moment of bipartisanship, the US House of Representatives on Wednesday passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.

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

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

Regulatory Recon: FDA Reverses on Amicus’ Fabry Disease Treatment; Sanofi Acquires Protein Sciences (11 July 2017) By Zachary Brennan - Published 11 July 2017

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

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, NICE, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

House, Senate Still Aim to Pass FDA User Fee Reauthorization Bill Before Delayed August Recess By Zachary Brennan - Published 11 July 2017

The US House of Representatives on Wednesday will take up a bill to reauthorize the US Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs, and though the Senate has not yet scheduled a time to take up the bill, it is expected to before thousands of FDA employees are laid off.

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

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

FDA Warns Indian Manufacturer for Equipment in 'State of Disrepair' By Zachary Brennan - Published 11 July 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to an India-based pharmaceutical manufacturer for equipment "in a state of disrepair" and failures in validating a manufacturing process for a drug that was distributed in the US from 2014 to 2016.

Categories: News, Asia, US, FDA, Crisis management, Drugs, Manufacturing

Tags: warning letter, Vista Pharmaceuticals, isoxsuprine hydrochloride

GAO: FDA Improved Expanded Access but More Clarity Necessary By Zachary Brennan - Published 11 July 2017

With the rise of Right-to-Try legislation across  the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA).

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

Tags: expanded access, compassionate use, GAO reports, adverse events

FDA Finalizes List of 1,003 Class II Device Types Exempt From 510(k) Requirements By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday finalized a list of 1,003 types of class II medical devices that the agency believes do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.

Categories: News, US, FDA, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: 510(k), device exemptions, 21st Century Cures, Class II medical devices

FDA Looks to Standardize PQ/CMC Data and Terminologies By Zachary Brennan - Published 10 July 2017

The US Food and Drug Administration (FDA) on Monday said it is drafting and seeking comment on the use of standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements for electronic submission.

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

Tags: CMC submissions, electronic submissions FDA, PQ/CMC data

Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017) By Zachary Brennan - Published 10 July 2017

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

Categories: News, Europe, US, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

FDA Speeding Generic Drug Approvals: Not Just Lip Service By Zachary Brennan - Published 10 July 2017

May and June 2017 have seen the most generic drug approvals since the US Food and Drug Administration (FDA) began tallying its monthly approvals, lending credence to FDA Commissioner Scott Gottlieb's pledge to speed approvals and lower drug costs.

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

Tags: FDA generic drug approvals, GDUFA, ANDA approvals

$500m Over 9 Years: FDA Details Plan for New 'Cures' Funds By Zachary Brennan - Published 07 July 2017

The US Food and Drug Administration (FDA) on Friday released a plan submitted to Congress for how it will use $500 million in potential new funding from the 21st Century Cures Act over the next nine fiscal years.

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Drugs, Medical Devices

Tags: 21st Century Cures, Cures timeline, FDA plan for Cures funds

Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising By Zachary Brennan - Published 07 July 2017

Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system."

Categories: News, Oceania, TGA, Advertising and Promotion, Biologics and biotechnology, Drugs, Medical Devices

Tags: TGA, drug advertising Australia

Regulatory Recon: UK Supreme Court Rules in Favor of Lilly Patents; HHS OIG Probes Alexion (7 July 2017) By Zachary Brennan - Published 07 July 2017

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

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

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

FDA Approves First New Sickle Cell Drug in Almost 20 Years By Zachary Brennan - Published 07 July 2017

The US Food and Drug Administration (FDA) on Friday granted approval to Emmaus Medical’s Endari (L-glutamine oral powder), the first treatment approved for patients with sickle cell disease in almost 20 years.

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

Tags: sickle cell, new FDA drug, Endari

EMA Restricts Use of Biogen MS Drug By Zachary Brennan - Published 07 July 2017

The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients "with highly active relapsing disease that has failed to respond to certain other treatment, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines."

Categories: News, Europe, EMA, FDA, Drugs, Labeling, Postmarket surveillance

Tags: Biogen, MS, EMA PRAC

Endo Pulls Opioid From US Market at FDA's Request By Zachary Brennan - Published 06 July 2017

Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market.

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Product withdrawl and retirement

Tags: Endo, Opana ER, opioids, opioid crisis

Generic Industry Group Sues Maryland Over Price Gouging Law By Zachary Brennan - Published 06 July 2017

The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly.

Categories: News, US, Business and Leadership, Generic drugs, Government affairs

Tags: AAM, generic drugs, Maryland drug price gouging law

10 Years in, EU Pediatric-Use Marketing Authorization Called a 'Disappointment' By Zachary Brennan - Published 06 July 2017

Biopharmaceutical companies and regulators across Europe have said that in the 10 years since the Pediatric Regulation took effect, some pediatric therapeutic areas have seen progress, though the pediatric-use marketing authorization (PUMA) has not lived up to expectations.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: pediatric-use marketing authorisation, EMA and PUMA, pediatric drugs

Chinese Heparin Contamination Questions Return With New FDA Warning Letter By Zachary Brennan - Published 05 July 2017

The US Food and Drug Administration (FDA) released a warning letter on Wednesday for China-based heparin contract testing lab, Shandong Analysis and Test Center, reigniting a debate over whether the questionable sources of heparin that led to almost 100 American deaths a decade ago have been rooted out.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, Chinese heparin, heparin contamination, FDA warning letters

CDC National Stockpile of Medical Products Could be at Risk in Public Health Emergency By Zachary Brennan - Published 05 July 2017

The US Department of Health and Human Services’ Office of Inspector General (OIG) warns that "systemic issues" with the Centers for Disease Control and Prevention’s (CDC) stockpile of vaccines, antibiotics, antidotes, antitoxins, medications and other supplies could place at risk approximately $7 billion of inventory and negatively affect readiness during a national emergency.

Categories: News, US, Biologics and biotechnology, Drugs, Government affairs

Tags: CDC, stockpile of medical products, vaccines, DSNS, OSSAM

Researchers Find Most Expert Speakers at FDA ODAC Meetings Receive Sizable Industry Payments By Zachary Brennan - Published 05 July 2017

Experts speaking on behalf of a pharmaceutical company at US Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings often receive sizable sums, raising questions about the relationships between the companies and the experts ahead of three ODAC meetings next week.

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

Tags: ODAC, Oncology Drug Advisory Committee, FDA advisory committees

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