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Regulatory Recon: CDER's Temple Tells Industry Not to Send in Every Adverse Event Report, Concerns Over New FDA Labeling Rule (15 February 2016)

Posted 15 February 2016 | By Michael Mezher 

Regulatory Recon: CDER's Temple Tells Industry Not to Send in Every Adverse Event Report, Concerns Over New FDA Labeling Rule (15 February 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.

In Focus: US

  • Critics See Accountability Risk if FDA Labeling Rule Changes Take Hold (StarTribune)
  • News About Superbugs Resistant to All Antibiotics Worsens (Forbes)
  • Google Bets on Health: 'The Most you can Lose is All Your Money' (Bloomberg)
  • One Hospital's Unusual Freebie for Newborns: Genetic Testing to see how Well They Metabolize Drugs (Forbes)
  • FDA's Temple to Industry: Don't Send in Every Adverse Event Report (Pink Sheet-$)

In Focus: International

  • South Korea's Pharma Price setting system under criticism (PharmaLetter-$)
  • China to Consolidate Drug Market, Promote Traditional Medicines (Reuters)
  • EU Launches New Medical Corps to Respond Faster to Emergencies (European Commission)
  • Increased GMP Enforcement by China Demands Regulatory Fluency (TanSheet-$)
  • China Moves to Prioritize and Accelerate Pediatric Drug Reviews (In-PharmaTechnologist)
  • GSK Fined $54M Over UK 'Pay-for-Delay' Deals (Fortune) (Law360-$) (SCRIP-$)

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US: Pharmaceuticals & Biotechnology

  • AbbVie goes for broke with Humira heir (EP Vantage)
  • US Continues to Face Drug Shortages (Policy and Medicine)
  • Experts Respond to FDA's Opioid Action Plan (MedpageToday)
  • Expanding Coercive Treatment Is The Wrong Solution For The Opioid Crisis (Harvard Bill of Health)
  • Letter: In OxyContin decision, FDA provides key guidance to serve a need in treating children (BostonGlobe)
  • Quantifying The Carnage: Biotech IPO Markets In Turmoil (LifeSciVC)
  • Demystifying Audit Trails in a GMP QC Laboratory (UngerConsulting)
  • 'Moonshot' Metaphor on Cancer Is a Failure to Communicate (NYTimes)
  • Telephus gets patents for superbug battling antibodies (BioPharma-Reporter)
  • Biosimilar Cost-Savings Needed To Balance Extrapolation Risk, Advisors Tell FDA (PinkSheet-$)
  • NORD Slams Orphan Indication Discussion At Biosimilar Advisory Committee (PinkSheet-$)
  • Have You Heard The Latest Rumor On Drug Pricing? Orrin Hatch Has (RPMReport-$)
  • Celltrion's Biosimilar Clinical Evidence Heavily Weighted By Ex-US Data (PinkSheet-$)
  • Extrapolated Biosimilar Indications Won't Get More Post-Marketing Requirements (PinkSheet-$)
  • Coming Attractions: New Drug Class Of 2016 Looks Strong So Far, But … (PinkSheet-$)
  • FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders (PinkSheet-$)

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

  • PIPELINE WATCH – Four Orphans, Two Breakthroughs And A Filing Withdrawal (SCRIP-$)
  • Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting (Press)
  • Lannett's subsidiary Kremers Urban Pharma gets US FDA nod for generic temozolomide capsules (PharmaBiz)

US: Medical Devices

  • US, EU medical device associations push 'regulatory cooperation' (MassDevice)
  • Zimmer Biomet wins 510(k) for Unite3D (MassDevice)
  • HHS adds more guidance for health app developers navigating HIPAA (mobihealthnews)
  • New Gene Discovery Could Lead To Earlier Lyme Test And Diagnosis (Forbes)
  • Clear Guide Medical Wins FDA Clearance for its SCENERGY Ultrasound-CT Fusion System (medGadget)
  • Chemence Medical Receives FDA Clearance for Exofin Tissue Adhesive (Press)

US: Assorted & Government

  • Justice Scalia's death leaves healthcare cases in limbo (ModernHealthcare) (SCRIP-$)
  • US Freezes Millions Of Dollars In Assets Of Rogue Lab Sales Force (CardioBrief)
  • Cannabidiol: (Clinical) Trials and Tribulations (National Law Review)
  • Res Ipsa Loquitur, Ipse Dixit, And A Non-Retained Expert (Drug and Device Law)
  • Should Presidential Candidates Be Vilifying Physicians For The High Cost Of Medical Care? (Forbes)
  • Our First of Many Drug cGMP Compliance Updates: CDER's First cGMP Warning Letter of 2016, to Ipca Laboratories Ltd., cites Data Integrity Violations (FDA Law Blog)
  • Ebola funding boost hides ongoing decline in neglected disease R&D (GHTC)
  • Global health R&D in the President's FY17 budget request (GHTC)
  • USPTO Tells Fed. Circ. Ethicon's Stent IP Claims Are Invalid (Law360-$)
  • FDA Rebuffs Allergan On Generic Restasis Tests (Law360-$)
  • What the Administration Actually Can Do on Drug Pricing (National Law Review)
  • Clawson Puts Forth Plan to Reduce The Spread of Zika in the US (Press) (Congress)

Upcoming Meetings & Events



  • CDSCO asks manufacturers of FDC piperacillin & tazobactam to insert adverse drug reaction on label (PharmaBiz)
  • Sun Pharma to ask FDA in Q1 FY17 for Halol re-inspection (Economic Times)
  • Rising spectre of cybercrime in the pharmaceutical sector (Economic Times)
  • Ranbaxy whistleblower Dinesh Thakur may set up patient advocacy group (Economic Times)
  • Pharmexcil urges health ministry for hearing before making final decision on licence fee (PharmaBiz)
  • Karnataka govt to spur new age biotech incubators with adequate funding to foster R&D (PharmaBiz)
  • Indian genomics lab MedGenome puts $10M toward 100K genome project in South Asia (Fierce)
  • IPA, jointly with US FDA, EMA, MHRA & CDSCO, to hold meet on Towards Excellence in Quality in Mumbai on Feb 23 (PharmaBiz)
  • Govt commences cervical cancer vaccination project in states of Kerala, Tamil Nadu (PharmaBiz)
  • IPC signs letter of intent with IMA to strengthen PvPI programme in India (PharmaBiz)
  • Govt to switch over from oral polio vaccination to injectable polio vaccination by 2020 (PharmaBiz)
  • No decision on pricing of patented drugs after 2 years of formation of inter-ministerial panel (PharmaBiz)


  • What's China doing to be innovative in pharma, biotech? (MedCityNews)


  • Guidance Document: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) - ICH Topic Q11 (Health Canada)

Zika Virus

  • Brazil reports more microcephaly cases under investigation (Reuters)
  • When Extinction Is a Humanitarian Cause (MIT Technology Review)
  • Zika Virus Test Is 'Weeks, Not Years' Away, WHO Says (NYTimes)
  • Zika scare prompts Philippines to advise women to postpone pregnancy (Reuters)
  • Brazil's President, Military Take to Streets in Informational Campaign, as Zika Cases Mount (WSJ-$) (Reuters)
  • Brazil Pushes Public to Do Its Part in Fighting Zika Spread (NYTimes)
  • Prepare for 'Guerrilla Warfare' With Zika-Carrying Mosquitoes, Experts Warn (NYTimes)
  • CDC: Puerto Rico seeing mounting cases of Zika virus infection (Washington Post)
  • Guillain-Barre on rise in 5 Latam countries, no proven link to Zika – WHO (Reuters)
  • Catholic Leaders Say Zika Doesn't Change Ban on Contraception (NYTimes)
  • More than 5,000 pregnant women in Colombia have Zika virus (Reuters)
  • In new advisory, WHO warns pregnant women against travel to Zika-affected countries (Washington Post)
  • Mysterious and fast-moving, Zika virus has world's health leaders scrambling (Washington Post)

Other International

  • Brazilian INMETRO Risk Management, Auditing Requirements Updated to Reflect IEC 60601 Changes (Emergo)
  • How Are Medtech's Emerging Markets Faring? (MDDI)
  • Tunisian Health Minister Calls for Promoting Partnership, Investment in Pharmaceutical Industry (PharmaAfrica)
  • Despite threats, thousands join anti-polio drive in Pakistan, a last bastion of the disease (Reuters)

General Health & Other Interesting Articles

  • When the Hospital Fires the Bullet (NYTimes)
  • Researchers Present Inner Workings of Ebola Vaccine Trial (DD&D)
  • How one longtime beat reporter is keeping the Medicaid story fresh (AHCJ)
  • U.S. agencies to study safety of artificial turf fields (Reuters)

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 @Michael_Mezher or send him an email at

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

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