Regulatory Focus™ > News Articles > Regulatory Recon: FDA's New Approach to Facility Inspections (25 March 2015)

Regulatory Recon: FDA's New Approach to Facility Inspections (25 March 2015)

Posted 25 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's New Approach to Facility Inspections (25 March 2015)

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

In Focus: US

  • FDA plans new approach to manufacturer inspections in India (In-Pharma) (FDA)
  • Compound Pharmacists Trade Group Discourages Supplying Execution Meds (Pharmalot) (WonkBlog)
  • FDA approves Emergent BioSolutions' anthrax treatment (Reuters) (SCRIP-$)
  • FDA Explains its Approval of Spectrum Pharma's Beleodaq (PubMed)
  • FDA's perspective on the new antidepressant vortioxetine (PubMed)
  • FDA Advisory Committee Reviews Sedation in Pediatric Clinical Trials (Tarius)
  • Health Affairs Op-Ed Takes on Using REMS to Delay Generics (HealthAffairs)
  • Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test (Press)
  • FDA Still Concerned About Latex Labeling (FDA)
  • Breakthrough Device Route, Registries On Wish List At Senate Hearing (Gray Sheet-$) (Press)

In Focus: International

  • Britain's Cameron apologizes over infected blood in 70s, 80s (Reuters)
  • NICE rules on Celgene's Imnovid, BI's Jardiance, Norgine's Targaxan (PharmaTimes) (PharmaPhorum)
  • Ipca Laboratories aims to make plants US FDA-compliant by December (India Times)
  • Underwriters Labs to train FDCA inspectors on audit norms (Business Standard)

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teamed up with the Combination Products Coalition (CPC) to offer a full day interactive program focused on FDA's newest draft guidance on Good Manufacturing Practices (GMPs) for combination products.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

  • FDA plans new approach to manufacturer inspections in India (In-Pharma) (FDA)
  • Compound Pharmacists Trade Group Discourages Supplying Execution Meds (Pharmalot) (WonkBlog)
  • FDA Explains its Approval of Spectrum Pharma's Beleodaq (PubMed)
  • FDA's perspective on the new antidepressant vortioxetine (PubMed)
  • FDA approves Emergent BioSolutions' anthrax treatment (Reuters) (SCRIP-$)
  • FDA Advisory Committee Reviews Sedation in Pediatric Clinical Trials (Tarius)
  • Antibiotics Poised For ‘Breakthrough’-Style Changes At FDA, Venture Capitalist Say (Pink Sheet-$)
  • Access to Experimental Drugs and State “Right to Try” Laws (Gordon & Rees)
  • Lawmakers propose allowing pharma companies to share some off-label information (MM&M)
  • Health Affairs Op-Ed Takes on Using REMS to Delay Generics (HealthAffairs)
  • FDA Widened Abilify Scope To Admit Generics, Otsuka Says (Law 360-$)
  • Oregon Lawmakers wrangle antibiotics use in livestock (Portland Tribune)
  • Doctors want specifics on biosimilar labels (MM&M)
  • Look-a-Like Injectables Prompt ASHP, ISMP to Issue National Alert (MPR)

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

  • VBL Therapeutics brain cancer drug study meets main goal (Reuters) (Press)
  • Lpath's kidney cancer drug fails mid-stage trial (Reuters) (Press)
  • Marinus Pharmaceuticals' Ganaxolone Receives FDA Orphan Drug Designation in PCDH19 Female Epilepsy (Press)
  • IP Group Reports Orphan Drug Status For Chronocort (Press)

US: Pharmaceuticals and Biotechnology: General

  • The diseases that are driving up American drug spending (QZ)
  • Lethal injection drug shortage brings return of firing squad in Utah (In-Pharma)

US: Medical Devices

  • Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test (Press)
  • FDA Still Concerned About Latex Labeling (FDA)
  • Breakthrough Device Route, Registries On Wish List At Senate Hearing (Gray Sheet-$) (Press)
  • MED Institute and FDA Sign Collaborative Research Agreement to Assess Radio Frequency Heating Safety of Passive Implants (Press)
  • Nearly 10,000 GE, Siemens MRI machines under FDA recall (Fierce)
  • EchoPixel’s Virtual Anatomy Models FDA-Cleared for Diagnosis, Surgical Planning (Xconomy)

US: Dietary Supplements

  • UNPA adopts 'no sale' policy for bulk powdered caffeine (NewHope360)

US: Assorted And Government

  • Senator: NIH and FDA Must Keep Pace with Today’s Cutting-edge Scientific Advances (Senate) (Senate)
  • New Batch of FDA Warning Letters (FDA)
  • Warren picks fight with 'Cures' author over NIH funding (SCRIP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • Cepheid Receives Emergency Use Authorization from FDA for Xpert Ebola Diagnostic Test (Press)

Europe

  • Britain's Cameron apologizes over infected blood in 70s, 80s (Reuters)
  • EC Approves Novo Nordisk's Saxenda (EC)
  • EC Approves The Medicine Company's Orbactiv (EC)
  • EC Approces ProFibrix's Raplixa (EC)
  • NICE rules on Celgene's Imnovid, BI's Jardiance, Norgine's Targaxan (PharmaTimes) (PharmaPhorum)
  • EMA Planning to Implement ISO Standards on Drug Identification (FDAnews-$)
  • Medicines regulator launches call for evidence on previously licensed oral hormonal pregnancy tests (MHRA) (MHRA)
  • NICE names new non-executive director (Pharmafile)
  • Scientific needs of HTA – methodological issues requiring further research attention (EUnetHTA)
  • Oncolytics Biotech Inc. Announces Receipt of Orphan Drug Status from the EMA for Ovarian Cancer (Press)
  • Police investigating arsenic poisoning in UK herbal supplement case (NutraIngredients)

India

  • Ipca Laboratories aims to make plants US FDA-compliant by December (India Times)
  • Underwriters Labs to train FDCA inspectors on audit norms (Business Standard)
  • Pharmexcil meets US FDA officials, discusses export related issues faced by industry (PharmaBiz)
  • Cipla to launch generic Hepatitis C drug 'Hepcvir' in India (India Times)

Australia

  • Safety alert - higher than expected revision rate when used without patella resurfacing (TGA)

Clinical Trials

  • AstraZeneca to Disclose Trial Data, but how Independent is its Review Panel? (Pharmalot)

General Regulatory And Interesting Articles

  • D.I.Y. DNA: Genetic testing at home is risky business (MacLeans)
  • New Research Shows We May Be Looking at Alzheimer's All Wrong (Bloomberg)
  • Drug that caused 'elephant man' side effect makes comeback after 2006 disaster (Reuters)

Regulatory Reconnaissance #521 – 25 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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