Regulatory Focus™ > News Articles > Regulatory Recon: Indian Regulators Prepare for Massive Hiring Spree (15 July 2014)

Regulatory Recon: Indian Regulators Prepare for Massive Hiring Spree (15 July 2014)

Posted 15 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Indian Regulators Prepare for Massive Hiring Spree (15 July 2014)

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In Focus: US

  • FDA proposed rule could delay import of excipients, PhRMA says (In-Pharma)
  • Benicar: FDA Once Again Reaches Conclusions At Odds With Its Own Staff (Forbes)
  • Ranbaxy Hits Back at Citizen Petition, Defending Exclusivity for Generics (FDA) (Law 360-$)
  • FDA Still Not Ready to Tackle Mobile Promotion (RegulatoryRx)
  • Roche says wins priority review for Avastin in cervical cancer (Reuters) (Press) (Pharma Times)
  • How FDA’s Culture Beats the ‘Least Burdensome’ Law (MDDI)
  • Proposed HIT Safety Center Likely To Have Light Touch (Health IT Outcomes)
  • House passes bill to modernize Federal Register (The Hill)

In Focus: International

  • CDSCO to go for massive recruitment drive, to appoint 5500 staff at Centre & states (PharmaBiz)
  • India Gives Go-Ahead to 41 Clinical Trials (PharmaBiz)
  • Bombay HC upholds Nexavar compulsory licensing decision (LiveMint)
  • Changes to industry code of conduct in UK (PharmaPhorum)
  • IPEC and IQ Consortium Team Up to Push for Excipient Approval Pathway (IPQ-$)
  • Eli Lilly NAFTA challenge ‘without merit,’ Ottawa says (Globe and Mail)

US: Pharmaceuticals and Biotechnology

  • FDA proposed rule could delay import of excipients, PhRMA says (In-Pharma)
  • Benicar: FDA Once Again Reaches Conclusions At Odds With Its Own Staff (Forbes)
  • Ranbaxy Hits Back at Citizen Petition, Defending Exclusivity for Generics (FDA) (Law 360-$)
  • FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 07/11/14) (OrphanDruganaut)
  • Relistor Can Be Approved For Chronic Pain Patients With Constipation, FDA Says (Pink Sheet-$) (BioCentury)
  • Acetaminophen Dose Change On Tap, FDA Plans To Mine OTC Use Data For Impact (Tan Sheet-$)
  • Testosterone Replacement Safety Gets FDA Panel Review As Lawsuits Pile Up (Pink Sheet-$)
  • After a Draw in Court, Zogenix and Massachusetts Battle Over ZOHYDRO ER May Have to Proceed to a Penalty Shootout Round (FDA Law Blog)
  • FDA Still Not Ready to Tackle Mobile Promotion (RegulatoryRx)
  • Accelerated Approval Unlikely for AstraZeneca’s Ovarian Cancer Drug (Reuters)
  • GlaxoSmithKline recalls painkiller in Puerto Rico (Reuters)
  • Progress Slow for FDA Mini Sentinel Surveillance System (Health Data Management)
  • Senator: Banning gays from blood donation is unfair ‘relic’ (The Hill)
  • Breakthrough therapy designation likely to positively influence oncologists (Pharma Letter-$)
  • FTC Urged to Probe Shire, Sanofi & Icahn Med School Over Fabry Drugs (Pharmalot)
  • Warner Chilcott To Pay $8M Over Generic Doryx Delay (Law 360-$)

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

  • Lundbeck, Otsuka submit brexpiprazole NDA (BioCentury) (MedCityNews) (SCRIP-$)
  • Roche says wins priority review for Avastin in cervical cancer (Reuters) (Press) (Pharma Times)
  • FDA to review Teva's bronchospasm inhaler (Pharma Times)
  • Neos Therapeutics Announces Positive Phase 3 Study Results for its Methylphenidate Extended-Release (XR) Oral Disintegrating Tablet (ODT) in ADHD Patients (Press)
  • Targacept's Alzheimer's hopeful misses the mark in Phase II (Fierce) (Press) (Reuters) (Pharmafile)
  • Janssen Pharmaceuticals Seeks Expanded Label for Invega Sustenna (Press) (Pharma Letter-$)

US: Pharmaceuticals and Biotechnology: General

  • PhRMA, BIO, GPhA ask court to trash California drug disposal law (Fierce)
  • Who gains from those drug discount deals? (Spoiler: Drug companies) (LA Times)
  • Oregon moves closer to limiting access on hepatitis C drugs as Senate investigation begins (Oregon Live)

US: Medical Devices

  • How FDA’s Culture Beats the ‘Least Burdensome’ Law (MDDI)
  • Novartis hopes to commercialise 'smart lens' within five years (Reuters) (Bloomberg)
  • Proposed HIT Safety Center Likely To Have Light Touch (Health IT Outcomes)
  • dorsaVi to Obtains 510(k) Clearance for ViMove (Press)
  • Titan Spine Receives FDA Clearance to Launch Endoskeleton TL Device for Lateral Spinal Fusion (Press)

US: Assorted And Government

  • House passes bill to modernize Federal Register (The Hill)
  • FDA Hiring New HR Director (FDA)
  • U.S. inspectors find further anthrax violations, mishandling (Reuters) (E&C)

Europe

  • Changes to industry code of conduct in UK (PharmaPhorum)
  • When a pharmaceutical company stops manufacturing a drug, what happens to the patients who think it saved their life? (BBC)
  • CellAct Pharma Receives Orphan Drug Designation in EU for CAP7.1 in Biliary Tract Cancers (Press)

India

  • CDSCO to go for massive recruitment drive, to appoint 5500 staff at Centre & states (PharmaBiz)
  • India Gives Go-Ahead to 41 Clinical Trials (PharmaBiz)
  • Bombay HC upholds Nexavar compulsory licensing decision (LiveMint)
  • Taxes on Clinical Trials in India to Rise (Business-Standard)

China

  • China approves Advanced Bionics' 'swimmable' hearing aid (Mass Device)
  • BGI’s Down Syndrome Test Gets CFDA Approval (Asian Scientist)

Japan

  • N-Chemiphar Adopts Seismic Isolation To Ensure Stable Japan Supply (PharmAsia-$)

Canada

  • Eli Lilly NAFTA challenge ‘without merit,’ Ottawa says (Globe and Mail)

Other International

  • IPEC and IQ Consortium Team Up to Push for Excipient Approval Pathway (IPQ-$)
  • Global Healthcare Compliance Outlook: Middle East and Africa Code of Pharmaceutical Practices (Policy and Medicine)
  • Philippines Drug Distributor Recalls Drug Used In Acute Heart Failure (PharmAsia-$)
  • New Contraceptive Shot Being Released in Africa (NYTimes)
  • Guided Therapeutics lands Mexico OK, creeps toward FDA resubmission (Mass Device)

Clinical Trials

  • Novartis Plans Alzheimer’s Study in Symptomless Patients (Bloomberg) (Reuters)
  • Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized (D&D Law)
  • What Drives Patient Interest in Clinical Trials? (PharmExec)

General Regulatory And Interesting Articles

  • Pill appearance affects how patients take their medications (MNT) (WaPo)
  • What Prescription? Most Patients Still Ignore Instructions (Pharmalot)
  • The Top Five Business Benefits of Compliance (PCM)
  • Better medication adherence in kids requires help from doctors, pharmacists & families (MedCity News)

Regulatory Reconnaissance #357 – 15 July 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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.


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