Search Results for Michael Mezher

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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

Senators Look to Overhaul Medical Device Inspections By Michael Mezher - Published 21 February 2017

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

Categories: News, US, CDRH, Government affairs, Medical Devices

Tags: Inspections

EU Court of Justice Clarifies Product Liability for Notified Bodies By Michael Mezher - Published 20 February 2017

The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives.

Categories: News, Europe, EC, Medical Devices, Quality

Tags: European Court of Justice, TÜV Rheinland, PIP Breast Implants, Notified Bodies

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

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

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

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

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

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

EMA Touts Growth of Post-Authorisation Study Database By Michael Mezher - Published 13 February 2017

The European Medicines Agency (EMA) on Friday announced it has published more than 1,000 post-authorization studies in a public online database.

Categories: News, Europe, EMA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance

Tags: Post-Authorisation Studies, PAS, EU PAS Register

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

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

PMDA Head Talks Priorities for 'Rational Medicine' By Michael Mezher - Published 10 February 2017

The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.

Categories: News, Japan, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Tatsuya Kondo, Rational Medicine, Regulatory Science

FDA Details Combination Product Postmarket Safety Reporting Requirements By Michael Mezher - Published 09 February 2017

The US Food and Drug Administration (FDA) is looking to clarify its expectations for combination product manufacturers adjusting to the agency's recently released final rule for postmarket safety reporting.

Categories: News, US, FDA, Combination products, Postmarket surveillance

Tags: Postmarketing Safety Reporting, PMSR, Combination Products, Record Retention

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

GAO: Adverse Event Reporting Limitations Delayed FDA Action on Power Morcellators By Michael Mezher - Published 08 February 2017

The Government Accountability Office (GAO) on Wednesday released the results of its year-and-a-half long investigation into the US Food and Drug Administration's (FDA) handling of laparoscopic power morcellators following reports that the devices spread cancer in patients being treated for uterine fibroids.

Categories: News, US, FDA, Medical Devices, Postmarket surveillance

Tags: Laparoscopic Power Morcellators, Power Morcellators, Government Accountability Office, GAO

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

EMA Explains How it Supports Article 58 Applications By Michael Mezher - Published 07 February 2017

The European Medicines Agency (EMA) on Tuesday released a document discussing the regulatory support available to drugmakers looking to submit applications via the Article 58 procedure in an attempt to increase access to medicines in low- and middle-income countries (LMICs).

Categories: News, Africa, Asia, Europe, Latin America and Caribbean, Middle East, EMA, WHO, Biologics and biotechnology, Drugs, Regulatory strategy

Tags: Article 58, Scientific Advice, Business Pipeline Meeting

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

MHRA Looks to Increase Medical Device Fees By Michael Mezher - Published 06 February 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Monday said it will move ahead with a proposal to increase and add to the fees it charges device makers and notified bodies.

Categories: News, Europe, EC, MHRA, Clinical, In vitro diagnostics, Medical Devices

Tags: Fees, Notified Bodies

Regulatory Recon: Express Scripts Says Prescription Spending Slowed in 2016; ACA Repeal Could Stretch to 2018 (6 February 2017) By Michael Mezher - Published 06 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