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India’s NPPA clarifies knee implant price caps amid market confusion
CDSCO has postponed fixed-dose combination (FDC) deadline
Further guidance notes on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
FDA in Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound drugs using nine bulk drug substances
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers
Amendments to the list of bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act
HPRA: Extension of FMD Use and Learn Period Ireland beyond September 2019
HPRA: Marketing authorization holders – Brexit regulatory and supply preparedness – Human Medicines
Drugs for treatment of partial-onset seizures: Full extrapolation of efficacy from adults to pediatric patients 2 years of age and older
FDA: Humanitarian Device Exemption (HDE) Program
FDA: Electronic Submissions; Data Standards; Support for Unified Code for Units of Measure
FDA: Acceptance review for De Novo classification requests
FDA: FDA and industry actions on De Novo classification requests: Effect on FDA review clock and goals
FDA: User fees and refunds for De Novo classification requests
TGA: Proposed changes to the medical device essential principles for safety and performance
Novartis Inhaler is the first device to be certified under MDR
EC explains new MDR, IVDR rules for designating expert device panels
EC: Guideline on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties
FDA: The Special 510(k) Program
FDA: The Abbreviated 510(k) Program
FDA: Refuse to Accept Policy for 510(k)s
FDA: Format for Traditional and Abbreviated 510(k)s
EMA: Preparedness of medicines’ clinical trials in pediatrics Recommendations by the Enpr-EMA working group on trial preparedness
FDA: Product-Specific Guidance for Generic Drug Development
MHRA: Public update: 2019, Strategy for pharmacopoeial public quality standards for biological medicines
HSA Stops Supply of Eight Brands of Ranitidine Products in Singapore
TGA: N-nitroso compounds in sartan blood pressure medicines
TGA: Consultation: Products used for and by people with disabilities Options for amendment to the Therapeutic Goods (Excluded Goods) Determination 2018
TGA: Fee-free period for sponsors to transition existing listed medicines to permitted indications has been extended
FDA: Evaluating Requests for and Conducting Product Development and Pre-Submission Pre-ANDA Meetings
MHRA: Brexit update – What a UK Responsible Person is
FDA: Safer Technologies Program for 3 Medical Devices – Draft guidance
HPRA: Brexit regulatory and supply preparedness – Medical Devices
FDA: Framework for the Safety and Performance Based Pathway
Biotronik first to land MDR certification for a high-risk device
FDA: Patient Engagement in the Design and 2 Conduct of Medical Device Clinical 3 Investigations
FDA: Preliminary List of Approved NDAs for Biological Products That Will Be Deemed to be BLAs on March 23, 2020
FDA: Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (draft guidance)
TÜV Rheinland Becomes 5th Notified Body Designated Under MDR
FDA: Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
MHRA: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that will apply in a no-deal Brexit