Regulatory Focus™ > News Articles > Regulatory Recon: In Farewell Speech, Hamburg Skeptical of Congressional Reform Efforts (30 March 20

Regulatory Recon: In Farewell Speech, Hamburg Skeptical of Congressional Reform Efforts (30 March 2015)

Posted 30 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: In Farewell Speech, Hamburg Skeptical of Congressional Reform Efforts (30 March 2015)

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

In Focus: US

In Focus: International

  • French agencies to probe claims of malpractice by former committee members (SCRIP-$) (ANSM)
  • EMA, PIC/S to Revise Annex 1 Sterile Manufacturing Guidelines (Gold Sheet-$)
  • EMA to Review Biogen's Biosimilar Remicade (Press)
  • EMA Guideline on adjustment for baseline covariates in clinical trials (EMA)
  • EU authorities’ joint market surveillance project proposals take shape (Clinica-$)
  • India Considers Whether to Regulate Stem Cells as Drugs (PharmaBiz)
  • China Web Pharmacies Would Have Alibaba Vying With Legacy Firms (Bloomberg)
  • Health Canada says fecal transplants should be restricted to trials (Globe and Mail)

Learn About--and Help Shape--FDA's Draft Combo Products GMP Guidance

  • When it comes to combination products, more regulations can mean more difficulties for regulatory professionals. That's why we've teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products. Learn from FDA experts and industry veterans in this unique experience that will help agency regulators to shape and clarify the final guidance document. Register for the 1 April 2015 program here.

US: Pharmaceuticals and Biotechnology

  • Hamburg’s Public Farewell Includes Rallying Cry For FDA Power (Pink Sheet-$) (Reuters) (Modern Healthcare) (SCRIP-$) (Press)
  • Makers of Generic Drugs Challenge F.D.A. Plan for Updated Warnings (NYTimes) (Pink Sheet-$) (Drug Kennel) (Law 360-$) (SCRIP-$)
  • White House Plan to Combat Antibiotic Resistance (White House) (White House)
  • FDA Defends Record on Sunscreen (WSJ-$)
  • U.S. plans to dig deeper on antibiotics given to livestock (Reuters)
  • CDER Ombudsman Releases Report (FDA)
  • NRDC: White House Antibiotics Plan Too Weak on Curbing Misuse of Drugs in Livestock (NRDC) (Pharmalot) (Fierce) (SCRIP-$)
  • Pew Applauds Administration's Antibiotic Plan (Pew)
  • More States Pass ‘Right to Try’ Laws, But Will These Make a Difference? (Pharmalot)
  • FDA rejects Adamis injection for treating acute allergies (Reuters)
  • NASH Drugs Soon May Have A Registrational Pathway, Finally (Pink Sheet-$)
  • Why drug names are so increasingly weird (AP)
  • Sandoz Can’t Dodge Cancer Drug Product Liability Suit (Law 360-$)
  • FDA’s Pediatric Data-Extrapolation Policies Questioned At Asthma Panel (Pink Sheet-$)
  • The Biosimilar Patent Dance, Labeling Exclusivity And The Power Of Unintended Innovation (Pink Sheet-$)
  • FDA Tries to Clear Up Continuous Manufacturing Ambiguities (Gold Sheet-$)
  • First Circuit Breathes New Life Into Branded Drug Preemption Defense (WLF)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • BioDelivery Sciences pain drug fails late-stage study (Reuters)
  • FDA Approves Label Update for ZYTIGA to Include Statistically Significant Overall Survival Results in Chemotherapy-Naive Men with Metastatic Castration-Resistant Prostate Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • The Cost of a Cure: Medicare Spent $4.5 Billion on New Hepatitis C Drugs Last Year (ProPublica)

US: Medical Devices

  • Vascular Solutions, CEO get ready to take on FDA conspiracy charges (StarTribune)
  • Federal Trade Commission cracking down on questionable mobile medical apps (Fierce) (Morgan Lewis)
  • Supply Chain Security Targeted By Draft Legislation – But How Burdensome Might It Be? Experts Weigh In (Gray Sheet-$)
  • FDA 'Taking a Very Light Touch' on Regulating the Apple Watch (Bloomberg)
  • Industry, Cancer Groups Draft Blueprint For PD-1 Companion Dx Approvals (Gray Sheet-$)
  • FDA grants exemption for fetal micro-pacemaker (Mass Device)
  • Obalon launches pivotal trial for weight-loss balloon (Mass Device)

US: Dietary Supplements

Upcoming Meetings and Events

Europe

  • French agencies to probe claims of malpractice by former committee members (SCRIP-$) (ANSM)
  • EMA, PIC/S to Revise Annex 1 Sterile Manufacturing Guidelines (Gold Sheet-$)
  • Europe pushes back verdict on Bristol immune system cancer drug (Reuters)
  • EMA to Review Biogen's Biosimilar Remicade (Press)
  • Guideline on adjustment for baseline covariates in clinical trials (EMA)
  • EU authorities’ joint market surveillance project proposals take shape (Clinica-$)
  • Guideline on clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis (EMA)
  • Draft concept paper on the need for revision of the guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials (EMA)
  • Reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (EMA)
  • Novartis drug gets 'Promising Innovative Medicine' status in UK (PharmaPhorum)
  • French Regulators Warn on Laparascopic Procedures (ANSM)
  • New policy for hydrates: proposed changes to titles of Ph.Eur. monographs (EDQM)
  • Deletion of reference to the heavy metals test (2.4.8) in individual monographs of the Ph.Eur. (EDQM)
  • The Medicines Company Receives European Commission Approval for Three Hospital Acute Care Products: KENGREXAL (cangrelor), ORBACTIV (oritavancin) and RAPLIXA (sealant powder) (Press)
  • UK gov't reaches deal with GSK for MenB jab (PharmaTimes) (Reuters) (PMLive) (Pharmafile)
  • Public consultation of the Draft Project Plan on “Transcatheter mitral valve repair in adults with chronic mitral valve regurgitation” (EUnetHTA)

India

  • DTAB to consult ICMR for including stem cell & cell based products under definition of new drug (PharmaBiz)
  • Medical devices industry annoyed over Centre’s failure to delink Schedule M III from Schedule M (PharmaBiz)
  • Build a culture of quality: USFDA official’s message to Indian drug companies (Business Line)
  • Indian Firms In Hot Chase To Market Generic Sovaldi (PharmAsia-$)
  • IPA asks govt to take immediate measures to curb the menace of misuse of prescription drugs (PharmaBiz)

Japan

  • Novocure Announces Japanese Approval of Optune (the NovoTTF-100A System) for Treatment of Recurrent Glioblastoma (Press)

China

  • China Web Pharmacies Would Have Alibaba Vying With Legacy Firms (Bloomberg)

Canada

  • Health Canada says fecal transplants should be restricted to trials (Globe and Mail)
  • CEN Biotech withdraws court challenge against Health Canada (Globe and Mail)

Other International

  • Brazilian Regulator Proposes Fast Track for Some Postmarket Changes (FDAnews-$)
  • New Zealand Transparency Advocates Call For Sunshine Act (Policy and Medicine)

General Regulatory And Interesting Articles

  • Measure kids’ medicines in metric units, not spoonfuls, doctors say (Reuters)
  • Past antibiotic exposure linked to increased diabetes risk (PharmJournal)
  • Google and Johnson & Johnson Team Up to Build Robot Surgeons (NBC)
  • Fecal transplantation 'more effective than previously thought' for C. diff infection (MNT) (Press)

Regulatory Reconnaissance #524 – 30 March 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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