Search Results for Michael Mezher

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Pazdur to Head New Oncology Center at FDA By Michael Mezher - Published 29 June 2016

Vice President Joseph Biden on Wednesday named the US Food and Drug Administration's (FDA) top oncologist, Dr. Richard Pazdur, to head the newly formed Oncology Center of Excellence (OCE).

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

Tags: Oncology Center of Excellence, OCE, Richard Pazdur

Regulatory Recon: Biden Hosts Moonshot Summit; FDA Rejects Lipocine Testosterone Drug (29 June 2016) By Michael Mezher - Published 29 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Issues New Guidance on Conflict of Interest for Advisory Committee Members By Michael Mezher - Published 28 June 2016

The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest.

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

Tags: Conflict of Interest, Advisory Committee

Regulatory Recon: FDA Approves Gilead's Epclusa for HCV; Pfizer to Invest $350M in China Biotech Center (28 June 2016) By Michael Mezher - Published 28 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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: Six Former FDA Commissioners Call for HHS-Independent FDA; Supreme Court Strikes Down Texas Abortion Clinic Rules (27 June 2016) By Michael Mezher - Published 27 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

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

Biosimilar User Fees: FDA and Industry Reach Agreement By Michael Mezher - Published 27 June 2016

The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May.

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

Tags: BsUFA, BsUFA II, Biosimilar User Fee Act

EMA Recommends Suspending Alkem Drug Over Flawed Studies By Michael Mezher - Published 24 June 2016

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India.

Categories: News, India, Europe, EMA, MHRA, Clinical, Generic drugs, Submission and registration

Tags: Alkem, riluzone, Good Clinical Practice, GCP

Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split? (24 June 2016) By Michael Mezher - Published 24 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News, EU Referendum, Brexit

Faulty Filter Prompts Recall of Leukocyte Reduction Device By Michael Mezher - Published 23 June 2016

The US Food and Drug Administration (FDA) on Thursday warned healthcare providers that a faulty filter in recently distributed lots of Haemonetics' Leukotrap RC System can result in higher than acceptable leukocyte counts in blood used in transfusions.

Categories: News, US, CBER, Blood, Product withdrawl and retirement

Tags: Haemonetics, Leukotrap

Regulatory Recon: Republicans Approve $1.1Bn to Fight Zika; UK Votes on 'Brexit' Today (23 June 2016) By Michael Mezher - Published 23 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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: Medicare Fund Will Run Out in 2028, IPAB Expected in 2017; A Look at Today's Immuno-Oncology Pipeline (22 June 2016) By Michael Mezher - Published 22 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

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

NICE Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta By Michael Mezher - Published 22 June 2016

The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).

Categories: News, Europe, NICE, Biologics and biotechnology, Drugs, Reimbursement, Submission and registration

Tags: Zykadia, Mekinist, Praluent, Repatha, Humira, Benlysta, NICE, NHS

Regulatory Recon: NIH Refuses to 'March-In' on Xtandi; Billionaire Sean Parker Funds First In-Human CRISPR Trial (21 June 2016) By Michael Mezher - Published 21 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

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

NIH Finalizes Single IRB Policy to Reduce Redundancies By Michael Mezher - Published 20 June 2016

The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year.

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

Tags: Single Institutional Review Board, sIRB, Single IRB

Regulatory Recon: Inovio Cleared for First Human Trial of Zika Vaccine; India to Release Revised Biosimilar Guidelines in July (20 June 2016) By Michael Mezher - Published 20 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

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

New Guidance Details FDA's Benefit-Risk Framework for Device Compliance, Enforcement Decisions By Michael Mezher - Published 17 June 2016

The US Food and Drug Administration (FDA) earlier this week released a new draft guidance detailing its approach to considering the benefits and risks for compliance and enforcement actions that could impact medical device availability.

Categories: News, US, FDA, Compliance, In vitro diagnostics, Medical Devices

Regulatory Recon: NIH Committee to Review First Human CRISPR Test; NICE Gives Speedy OK to BMS Melanoma Combo (17 June 2016) By Michael Mezher - Published 17 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Cites Pharmaceutics International for GMP Issues at Two US Sites By Michael Mezher - Published 16 June 2016

The Medicines and Health Care products Regulatory Agency (MHRA) on Wednesday cited US-based contract manufacturing organization Pharmaceutics International, Inc. (Pii) for critical deficiencies at two of its Maryland facilities.

Categories: News, Europe, US, EMA, MHRA, Drugs, Manufacturing

Tags: GMP Inspection, EudraGMP, Pharmaceutics International

FDA Issues Draft Guidance on Critical Quality Attributes for Chewable Tablets By Michael Mezher - Published 16 June 2016

The US Food and Drug Administration (FDA) on Thursday issued new draft guidance covering the quality attributes drugmakers should consider when developing chewable tablets.

Categories: News, US, FDA, Clinical, Drugs, Submission and registration

Tags: Chewable Tablets, Draft Guidance, Critical Quality Attributes

Regulatory Recon: Democrats Call on FDA to Change Blood Donor Rule; CFDA to Require Self Inspections for Class II & III Device Distributors (15 June 2016) By Michael Mezher - Published 15 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Drugs, Medical Devices, Regulatory intelligence

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

FDA Issues Final Rule on Symbols for Device Labels By Michael Mezher - Published 15 June 2016

The US Food and Drug Administration (FDA) on Wednesday issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards.

Categories: News, US, FDA, In vitro diagnostics, Labeling, Medical Devices

Tags: Final Rule, Symbols

Woodcock: Antibiotics Pipeline is 'Fragile and Weak' By Michael Mezher - Published 14 June 2016

At a congressional hearing in Washington, DC on Tuesday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said that current incentives are not enough to overcome the challenges of developing new drugs to fight bacterial infections.

Categories: News, US, FDA, Clinical, Drugs, In vitro diagnostics, Preclinical, Research and development

Tags: Antimicrobial Resistance, AMR, Antibiotics, Janet Woodcock, Energy & Commerce Committee, GAIN Act, ADAPT Act

Regulatory Recon: FDA Approves New Obesity Device; Novo Diabetes Drug Cuts Heart Risks by 13 Percent (14 June 2016) By Michael Mezher - Published 14 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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: PaxVax Gets Priority Review Voucher for Cholera Vaccine; Walgreens Ends Theranos Deal (13 June 2016) By Michael Mezher - Published 13 June 2016

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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

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

FDA Issues New Guidance on Osteoporosis Drug Development By Michael Mezher - Published 13 June 2016

The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments.

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

Tags: Osteoporosis, Animal studies, Bone quality