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Filtering on: "topics drugs"

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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

21st Century Cures Act Deadlines Approach in March and June By Zachary Brennan - Published 22 February 2017

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

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

Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA

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

FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue By Zachary Brennan - Published 21 February 2017

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Research and development

Tags: oncology, Pazdur, Oncology Center of Excellence, FDA cancer drug approvals

Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017) By Nick Paul Taylor - Published 21 February 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs

Tags: stents in India, substandard drugs, complementary medicines

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

EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research By Zachary Brennan - Published 17 February 2017

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: News, Europe, EC, Compliance, Crisis management, Drugs, Ethics, Government affairs, Human cell and tissue, Medical Devices, Preclinical

Tags: animal research, drug safety testing, non-human primates, European Commission Opinion

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

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

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern By Michael Mezher - Published 16 February 2017

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

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

Tags: GAO, Government Accountability Office, Drug Shortages

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

CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics By Michael Mezher - Published 16 February 2017

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: News, EMA, FDA, Clinical, Drugs

Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative

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

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

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

FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials By Michael Mezher - Published 15 February 2017

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.

Categories: News, US, CBER, Advertising and Promotion, Blood, Compliance, Drugs

Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials

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

EMA Reviews Safety of PAH Medicine Following 5 Deaths in France By Zachary Brennan - Published 14 February 2017

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

Categories: News, Europe, EMA, Crisis management, Drugs, Government affairs

Tags: Uptravi, PRAC, Actelion

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

CDRH and CDER Send Warning Letters to Six Asian Companies By Zachary Brennan - Published 14 February 2017

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: News, Asia, US, FDA, Active pharmaceutical ingredients, Drugs, Government affairs, Manufacturing, Medical Devices, Quality

Tags: warning letters, China drug manufacturing, India drug manufacturing

FDA Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition By Michael Mezher - Published 14 February 2017

The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis.

Categories: News, US, FDA, Generic drugs, Submission and registration

Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence

Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike By Zachary Brennan - Published 14 February 2017

Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

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

Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices