Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 August 2013)

Regulatory Reconnaissance (23 August 2013)

Posted 23 August 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance.

In Focus: US

  • Public Citizen's Wolfe questions FDA's diet drug approvals (Pharmafile)
  • Everything you've ever wanted to know about how FDA 483s are written (FDAzilla)
  • Mylan Confirms Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg (Mylan)
  • New U.S. clinical trial poses risks to premature babies: watchdog (Reuters)
  • Allergan Puts FDA's Restasis Bioequivalence Guidance To The Test To Prove It's Flawed (Pink Sheet)
  • A Pfizer Whistleblower, Lipitor Marketing And Free Speech Rights (Pharmalot)
  • FDA Contract: Characterization of Drug Use in Poultry Producing Animals (FDA)
  • Interview: CDRH's Shuren Signals More Guidance, Enhanced Pre-Market Payer Role (Gray Sheet)
  • Glucose Test Accuracy Concerns Prompting FDA Action (Medscape)
  • Hospital Stakeholders Push For Fast UDI Implementation In Meeting With OMB (IHP)

In Focus: International

  • Electronic Labelling 101: How to Comply with EU Regulations (MDDI)
  • EMA Releases ICH Q3D, M8 Guidelines for Consultation (EMA) (EMA)
  • India's DCGI asked to check quality of drugs sold by Ranbaxy (India Times)
  • Indian Health ministry constitutes expert panel to guide DCGI on regulation of biotech products (PharmaBiz)
  • Expert Reveals Flaws In China's Clinical Trial Regulation (PharmAsia)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Study to Investigate the Sensitivity of Pharmacokinetics in Detecting Differences in Physicochemical Properties of the Active in Suspension Nasal Products for Local Action (FDA)
  • Public Citizen's Wolfe questions FDA's diet drug approvals (Pharmafile)
  • Everything you've ever wanted to know about how FDA 483s are written (FDAzilla)
  • Mylan Confirms Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg (Mylan)
  • New U.S. clinical trial poses risks to premature babies: watchdog (Reuters)
  • Allergan Puts FDA's Restasis Bioequivalence Guidance To The Test To Prove It's Flawed (Pink Sheet)
  • A Pfizer Whistleblower, Lipitor Marketing And Free Speech Rights (Pharmalot)
  • FDA Contract: Characterization of Drug Use in Poultry Producing Animals (FDA)
  • Lupin gets USFDA nod for tuberculosis drug (India Times)
  • Dr Reddy's recalls anti-gas drug from US market (India Times)
  • Unapproved Fecal Transplant in CA Hospital Draws Fine (Health Leaders Media)
  • Mystery doc cited for handing insider trial info to SAC trader (Fierce) (Fierce)
  • Pharma and the Environment: A Different Kind of Drug Safety (Cutting Edge Information)
  • FDA Announces Phibro Animal Health Requests Voluntary Withdraw of Application for Medicated Poultry Feed (FDA)
  • Contested Biosimilars Bill Clears Committee (California Healthline) (Bill) (Pharmalot)
  • Transdermal Delivery Solutions Subsidiary, Hormone Replacement Technologies, Receives FDA Approval to Begin Pivotal Clinical Trials of Testagen TDS for the Treatment of Low Testosterone (TDS)
  • IntelGenx Receives Paragraph IV Certification Letter from Wockhardt on Submission of ANDA for Forfivo XL (IntelGenx)
  • Mallinckrodt's higher-dose Pennsaid gets 2nd FDA look, as firm faces lawsuit (SCRIP)
Pharmaceuticals: General
  • An Effort to Expand Access to a Drug That Could Save Victims of Overdoses (NYTimes)
Medical Devices
  • Interview: CDRH's Shuren Signals More Guidance, Enhanced Pre-Market Payer Role (Gray Sheet)
  • Glucose Test Accuracy Concerns Prompting FDA Action (Medscape)
  • Hospital Stakeholders Push For Fast UDI Implementation In Meeting With OMB (IHP)
  • Becton false advertising and antitrust lawsuit heads to trial (Mass Device)
  • Class 1 Recall: Stryker Spine Oasys Midline Occiput Plate (FDA)
  • ACLU, Others Blast Myriad Bid To Halt Rival Gene Tests (Law 360)
Assorted And Government
  • Entrepreneur's drug database brings healthcare big data to the ordinary person (MedCity News)
  • Picture This - FDA Taking Inspection Photos (Law 360)
  • NARB: 'Zicam, the Pre-Cold Medicine' is not interpreted by the consumer as a prevention claim (DSN)
  • FTC chair promises robust regulation of big data (GovHealthIT)
Upcoming Meetings And Events
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Electronic Labelling 101: How to Comply with EU Regulations (MDDI)
  • ICH guideline Q3D on elemental impurities (EMA)
  • ICH guideline M8 on eCTD - questions and answers (EMA)
  • UK reinstates reformulated Dexaprine after ban (Nutra-Ingredients)
  • No room for 'biased' patients and doctors in Germany's AMNOG system (SCRIP)
  • European Medicines Agency closed 26 August 2013 (EMA)

Asia

  • DCGI asked to check quality of drugs sold by Ranbaxy: Government (India Times)
  • Health ministry constitutes expert panel to guide DCGI on regulation of biotech products (PharmaBiz)
  • India is hotbed of pharma manufacturing; innovation next? (SCRIP) (BioSpectrum)
  • Expert Reveals Flaws In China's Clinical Trial Regulation (PharmAsia)

Other International

  • Australian device pre-market assessment changes: submissions, costs and timelines (Clinica)

General Regulatory And Interesting Articles

  • Mood disorder drugs may triple kids' diabetes risk (CBS) (Reuters) (Pharmalot)
  • Cardiac Safety Monitoring - Benefits and Risks Assessment and the Regulatory Environment (BioClinica)
  • Life, Interrupted: A Test of Faith (in Clinical Trials) (NYTimes)

Regulatory Reconnaissance #138  - 23 August 2013

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.


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