Regulatory Recon: FDA's New Commissioner Plans to 'Hold Course' (21 April 2015)
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- FDA acting commissioner Ostroff plans to hold course (BioCentury) (FDA) (Pink Sheet-$) (Policy and Medicine)
- An Inside Look at How FDA Approves Cancer Drugs (BioCentury)
- FDA's rocket docket (BioCentury)
- Shifting positions, Genervon now says it has yet to file for ALS drug OK (Fierce)
- FDA Bashes Otsuka Bid To Block Abilify Generics (Law 360-$)
- Teva to pay $512 million to settle claims of delayed generic Provigil (Reuters) (NYTimes) (Pink Sheet-$) (Bloomberg)
- Recent Scandals Call into Question FDA’s 510(k) Process (MDDI)
- Endo settles more than 350 vaginal mesh suits (Fierce)
- Details could come Wednesday for new ‘cures’ bill (The Hill)
In Focus: International
- Belgium, Netherlands plan joint purchase of rare disease drugs (Reuters)
- Clinical trials for medicines: authorisation assessment performance (MHRA)
- EU firms facing new requirements for orphan drug designation (SCRIP-$)
- PIC/S Adopts Same Risk-Management GMPs as EU (FDAnews-$)
- Taiwan drug regulator plans online database after drug recall spate (Fierce)
- Global Pandemic of Fake Medicines Poses Urgent Risk (NIH) (Washington Post) (Reuters)
Take Your Regulatory Career to the Next Level With Executive Training
- Now more than ever, senior regulatory professionals must bridge science, regulation, business and strategy. RAPS’ Executive Development Program at the Kellogg School of Management is the only program of its kind that caters exclusively to experienced regulatory professionals. It is an exceptional opportunity to strengthen your management and leadership skills over four intensive days in an intimate learning environment. Register for the Executive Development Program here.
US: Pharmaceuticals and Biotechnology
- An Inside Look at How FDA Approves Cancer Drugs (BioCentury)
- FDA's rocket docket (BioCentury)
- Shifting positions, Genervon now says it has yet to file for ALS drug OK (Fierce)
- FDA Bashes Otsuka Bid To Block Abilify Generics (Law 360-$)
- Acting Commissioner Ostroff Makes PDUFA Reauthorization Top Priority (FDAnews-$)
- Drugmakers Diss FDA Study On Pill Shapes, Sizes (Law 360-$)
- Public Meeting on Breast Cancer Patient-Focused Drug Development (FDA)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- Phase III failure a death knell for Ampio? (SCRIP-$) (Fierce) (BioCentury)
- Genentech to move anti-PD-1 to Phase III in triple-negative breast cancer (BioCentury)
- Pfizer Phase 3 Study Of Inotuzumab Ozogamicin Meets Primary Endpoint In Adult Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia (Press)
- Novartis MS drug scores positive late-stage trial result (Pharmafile)
- PLEGRIDY (Peginterferon Beta-1a) Three-Year Data Presented at AAN Annual Meeting Support Long-Term Safety and Efficacy in Multiple Sclerosis Patients (Press)
US: Pharmaceuticals and Biotechnology: General
- Teva to pay $512 million to settle claims of delayed generic Provigil (Reuters) (NYTimes) (Pink Sheet-$) (Bloomberg)
- Drug R&D Costs: $1.7 Billion And Rising (Press)
- Abuse-Deterrent Formulations Put Dent in Opioid ODs (MedPage Today) (Reuters)
US: Medical Devices
- Recent Scandals Call into Question FDA’s 510(k) Process (MDDI)
- Endo settles more than 350 vaginal mesh suits (Fierce)
- A Few Words With Acting FDA Commish Stephen Ostroff (Gray Sheet-$)
- More Data Integrity Guidance From FDA Would Help (Gray Sheet-$)
- FDA approves new device for surgical sealing during cranial procedures (Fierce)
- Color Genomics Sells $249 Breast Cancer Gene Test to Masses (Bloomberg)
- Biotronik wins FDA nod for high-energy ICD (Mass Device) (Press)
US: Assorted And Government
- Details could come Wednesday for new ‘cures’ bill (The Hill)
- FDA acting commissioner Ostroff plans to hold course (BioCentury) (FDA) (Pink Sheet-$) (Policy and Medicine)
- Senators Introduce Bill to Strengthen Personal Care Product Oversight (Feinstein) (NYTimes) (Congress)
Upcoming Meetings and Events
- RAPS' FDA Advisory Committee Meeting Tracker
- Atlanta, 22/29 April 2015 – Preparing for the US Regulatory Affairs Certification (RAC) Exam (Four-Part Series)
- 18 April 2015 – Midwest Region Regulatory Career Day
- Florida, 6 May 2015 – Canadian Medical Devices Regulations
- Philadelphia, 7 May 2015 – Global UDI Compliance - Challenges and Opportunities of Device Identification
Europe
- Belgium, Netherlands plan joint purchase of rare disease drugs (Reuters)
- Clinical trials for medicines: authorisation assessment performance (MHRA)
- EU firms facing new requirements for orphan drug designation (SCRIP-$)
- Indication of major added benefit for Xtandi in over 75-year-olds, say IQWiG (PharmaLetter-$)
Australia
- Joint replacement manufacturers: are you entitled to a regulatory refund in Australia? (Clinica-$)
- Australian government enhances website to support clinical trials (PharmaLetter-$)
Other International
- PIC/S Adopts Same Risk-Management GMPs as EU (FDAnews-$)
- Taiwan drug regulator plans online database after drug recall spate (Fierce)
- Harmonised Southeast Asia regulation complete by end of year (NI-USA)
General Regulatory And Interesting Articles
- Global Pandemic of Fake Medicines Poses Urgent Risk (NIH) (Washington Post) (Reuters)
Regulatory Reconnaissance #540 – 21 April 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 [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.