Regulatory Focus™ > News Articles > Regulatory Recon: FDA Bans Imports from Another Indian Manufacturing Site (15 September 2015)

Regulatory Recon: FDA Bans Imports from Another Indian Manufacturing Site (15 September 2015)

Posted 15 September 2015 | By Zachary Brennan 

Regulatory Recon: FDA Bans Imports from Another Indian Manufacturing Site (15 September 2015)

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

In Focus: International

  • US bans another Indian drug plant over production quality (Reuters) (Economic Times) (FDANews-$)
  • Guideline on the evaluation of medicinal products for the treatment of chronic constipation (including opioid induced constipation) and for bowel cleansing (EMA)
  • European Commission Seeks Scientists For Newly Merged Committee (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • America's most admired lawbreaker: On J&J and Risperdal (Huffington Post)
  • American Copycats: Can Biosimilars Catch On And Cut Costs In U.S.? (Xconomy)
  • New Treatments for Deadly Idiopathic Pulmonary Fibrosis (WSJ-$)
  • Old boy biotech (Nature Biotechnology)
  • Mylan upbeat on prospects for $27bn Perrigo takeover (FT-$)
  • Merck Serono breaks ground on $72M R&D center (FierceBiotech)
  • Pharma brand launch: Does order to market still matter? (Cutting Edge)
  • Peter Thiel Explains Biotech Investing Rationale: Get Rid of Randomness (MIT Tech Review)
  • J&J: Biosimilars will not replicate generic levels of competition or substitution (BioPharma-Reporter)
  • Prions In the News (Unfortunately) (In the Pipeline)
  • Medidata trial data tech to benefit from Cures (Outsourcing-Pharma)
  • FTC Faces Uphill Battle In AndroGel Pay-For-Delay Suit (Pink Sheet-$)
  • Biosimilar Labeling: Sandoz Makes Good-For-The-Goose Defense (Pink Sheet-$)

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

  • Panel Says Aspirin Lowers Heart Attack Risk For Some, But Not All (NPR) (NY Times) (NBC) (Reuters) (WSJ)
  • XenoPort's psoriasis drug effective in mid-stage study (Reuters)(Press) (FierceBiotech)
  • CardioBrief: A Premature SPRINT to the Finish Line (MedPage Today)
  • Amicus Therapeutics Plans to Submit NDA for Migalastat for Fabry Disease Following Positive Pre-NDA Meeting With FDA (Press) (FierceBiotech)
  • Vanda Announces FDA Has Accepted for Review the Fanapt Supplemental NDA (Benzinga)
  • NIH Awards $7.5 Million Grant For AgeneBio HOPE4MCI Phase 3 Clinical Trial (Press)
  • Avillion Announces Completion Of Enrolment In Phase III BFORE Trial (Press)
  • Raptor Pharmaceutical rapped after RP103 disappoints in pediatric NASH (BioWorld)
  • Antivenoms for Snakebite Envenoming: What Is in the Research Pipeline? (PLOS)
  • AbbVie/J&J’s Imbruvica Marches Toward Front-Line CLL Indication With sNDA (Pink Sheet-$)

US: Medical Devices

  • Sony, Olympus to unveil high-definition endoscope (Reuters)
  • Medtronic First to Receive FDA Approval for MR-Conditional Implantable Cardioverter Defibrillator System (Press)
  • Philips and Dutch Radboud university medical center introduce first diabetes prototype app with integrated online community (Press) (MedCity News)
  • Medical devices firm Medtronic to provide relief to US patients (Economic Times)
  • How to define medical device design inputs and outputs (MedCity News)
  • Biosensor developer Valencell raises $2.64M following patent approvals (MedCity News)
  • Class 2 Device Recall CIVCO Shoulder Retractors (FDA)
  • Class 3 Device Recall Pointe Scientific, Med Test (FDA)
  • Covidien Investor Lambasts Deal Over $43B Medtronic Merger (Law360-$)
  • Olympus Hit With 3rd Pa. Suit Claiming Device Spread Cancer (Law360-$)

US: Assorted and Government

  • Welcoming FDA’s New Overseas Leaders (FDAVoice)(Focus)
  • FDA enforcement report (FDA)
  • Lobby Day Confirms General Goodwill Toward FDA Among Hill Staff (Alliance for Stronger FDA)
  • FDA approves filler for 'Five-Minute Facelift' (
  • FDA Issues Draft Guidance Regarding Menu Labeling Requirements (FDA Law Blog)
  • The Flood Gates Are Open: Amarin’s Win Spurs another First Amendment Challenge to the FDA’s Regulation of Off Label Promotion (Drug and Device Law)
  • Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs (DOJ)

Upcoming Meetings and Events              


  • Dexcom gets CE Mark for G5 continuous glucose monitor (MedCity News)
  • Valtech, Soon To Be Part Of HeartWare, Earns CE Mark For Mitral Repair Device (Clinica-$)
  • Irish Regulatory Agency Seeks New Head After O'Mahony Departure (SCRIP-$)


  • Australian Biotech Cautious Of Proposed Expedited Review Process for Novel Devices (SCRIP-$)
  • Submissions received: Draft OTC Medicine Monographs for Bromhexine hydrochloride; Dextromethorphan hydrobromide; Laxatives: Docusate sodium and/or sennosides; Hand sanitisers (TGA)


  • Abbott Co to hold global board meet in India (India Times)
  • Indian Pharmaceutical Alliance drops opposition to Gilead's Sovaldi patent (PharmaLetter-$)


Ebola Outbreak

  • New Ebola death reported in northern Sierra Leone (AP) (AFP)
  • Hail to the chiefs (Economist)
  • Crucell, Bavarian Land $28.5m U.S. Ebola Vaccine Award (SCRIP-$)

Other International

  • IBM, Medtronic win grant to launch digital medicine incubator in Israel (MedCity News)
  • Medical Device Software Guidelines Step Closer For AHWP Countries (SCRIP-$)

General Health and Other Interesting Articles

  • 732,000: American Lives Saved by Vaccination (NY Times)
  • Michigan resident tests positive for plague (Reuters)
  • Patients' Rights Questions Hang Over Mental Health Debate (Roll Call)
  • Psychiatrist Shortage Worsens Amid 'Mental Health Crisis' (Forbes)

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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