FDAnews Guide To International Pharma Regulation 2011

2y ago
10 Views
2 Downloads
641.04 KB
13 Pages
Last View : 11d ago
Last Download : 1m ago
Upload by : Ronnie Bonney
Transcription

FDAnews Guide to International PharmaRegulation: 2011 EditionTable of ContentsAppendices are noted with an asterisk* and can be found in the back of thisbook.IntroductionActive Pharmaceutical IngredientsEMEA: Drugmakers Must Apply for Changes to APIs, 2/10 . . . . . . . . . . . . . . . . . . . . . . . . . 3Post-Authorisation Procedural Advice: Human Medicinal Products*Japan Ends Grace Period for Foreign API Makers, 3/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4China-Japan-Korea Tripartite Cooperation and Japan PMDA’s Perspective onPharmaceutical Quality*WHO Drafts Guideline on Production, Control of Specified Starting Materials, 5/10 . . . . . . 5Brazil Outlines Requirements for Stability Testing of APIs, 8/10 . . . . . . . . . . . . . . . . . . . . . . 6Adverse Drug ReactionsChina SFDA 2009 Annual Report Counts 600,000 Adverse Events, 5/10 . . . . . . . . . . . . . . . 9Signal Detection Helps Identify Adverse Events Earlier, 6/10. . . . . . . . . . . . . . . . . . . . . . . . 10EU Parliament Passes Pharmacovigilance Requirementto Report Adverse Reactions, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Antibacterial DrugsEndpoints, Trial Design for Skin Infection Drugs Are Focusof US FDA Draft Guidance, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Guidance for Industry – Acute Bacterial Skin and Skin Structure Infections: DevelopingDrugs for Treatment*Anti-Epileptic DrugsNeed for Pediatric Trials of Anti-Epileptic Drugs Addressed in EMA Guidance, 9/10 . . . . 19Guideline on Clinical Investigation of Medicinal Products in the Treatment of EpilepticDisorders*iii

iv FDANEWS GUIDE TO INTERNATIONAL PHARMA REGULATION: 2011 EDITIONAntiplatelet DrugsEMA Updates Its Warning on Clopidogrel, PPI Use, 4/10 . . . . . . . . . . . . . . . . . . . . . . . . . . 23Interaction Between Clopidogrel and Proton-Pump Inhibitors*AntiviralsUS FDA Minimizing Noninferiority Trials in Guidance on DevelopingDirect Antivirals for Hep C, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Guidance for Industry – Chronic Hepatitis C Virus Infection: Developing DirectActing Antiviral Agents for Treatment*Application, Approval, Authorization, Registration, Regulatory ReviewMHRA May Allow Needed Drugs to Be Sold Before Approval, 1/10 . . . . . . . . . . . . . . . . . 31Earlier Access to New Medicines in the UK*UK Marketing Authorization Changes Must Follow EU Regulations, 1/10 . . . . . . . . . . . . . 32Guideline on the Details of the Various Categories of Variations to the Terms of MarketingAuthorisations for Medicinal Products for Human Use and Veterinary MedicinalProducts*European Directorate Updates Process for Amending, Renewing CEPs, 2/10 . . . . . . . . . . . 34Procedures for Management of Revisions/Renewals of Certificates of Suitability to theEuropean Pharmacopoeia Monographs*Guideline on Requirements for Revision/Renewal of Certificates of Suitability to theEuropean Pharmacopoeia Monographs*New Zealand Proposes Revisions to Medicines Regulations, 3/10 . . . . . . . . . . . . . . . . . . . . 35Consultation on Proposed Amendments to Regulations Under the Medicines Act 1981*EU, FDA Question J&J Trials, Zeftera Withdrawn from Canada, 4/10. . . . . . . . . . . . . . . . . 37Multi-Site Manufacturing Licenses Subject to TGA Criteria, 4/10 . . . . . . . . . . . . . . . . . . . . 38Therapeutic Goods (Multi-Site Manufacturing) Licenses Guidelines of 2010*Canada Plans New Submission Route for Extraordinary Use New Drugs, 5/10 . . . . . . . . . . 39Regulations Amending the Food and Drug Regulations (1319 – New Drugs forExtraordinary Use)*US FDA Creates New Division to Address ANDA Backlog, 6/10 . . . . . . . . . . . . . . . . . . . . 41Australian PARs on Prescription Drugs to Include Product Information, 7/10 . . . . . . . . . . . 42TGA Australian Public Assessment Report (AusPAR) for Prescription Drugs – GuidanceDocument Version 1.2*Philippines Creates Its Own FDA to Tighten Regulation of Drugs and Devices, 8/10 . . . . . 43The Rules and Regulations Implementing Republic Act No. 9711, the Food and DrugAdministration Act of 2009*Australia’s TGA Set to Implement More Streamlined Review Processfor Pharmaceuticals, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Table of Contents vMHRA Audit: One-Third of Variations Notices DeniedUnder New EU Regulations, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Singapore Issues Guidance for Abridged Evaluation of New Drug Applications, 10/10 . . . 47Guidance on Medicinal Product Registration in Singapore*India Outlines Requirements for CTDs in New Drug Applications, 11/10 . . . . . . . . . . . . . . 49Guidance on Clinical Trial Inspection*TGA Lists Requirements for Submissions Under StreamlinedDrug Review Process, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51Drugmakers Will Have Increased Say in British Columbia Review Process, 12/10 . . . . . . . 52US FDA Promises Less Assistance for Drug Name Review Process, 12/10 . . . . . . . . . . . . . 53Guidance for Industry – Contents of a Complete Submission for the Evaluation ofProprietary Names*Asthma DrugsUS FDA Issues Final Rule, Extends Deadline for ODS Inhaler Ban, 5/10 . . . . . . . . . . . . . . 57Use of Ozone-Depleting Substances: Removal of Essential Use Designation (Flunisolide,etc.)*Bioequivalence TestingBioequivalence Study Requirements Outlined in New EMEA Guidance, 2/10. . . . . . . . . . . 61Guideline on the Investigation of Bioequivalence*BiologicsHealth Canada Issues Draft Guidance on Follow-On Biologics, 3/10 . . . . . . . . . . . . . . . . . . 65Guidance for Sponsors – Information and Submission Requirements for Subsequent EntryBiologics (SEBs)*US FDA Proposes Biologics Rule to Ease Restrictions on Constituent Materials, 4/10 . . . . 66Proposed Rule: Revision of the Requirements for Constituent Materials*Australia Would Separate Biologicals Regulatory Regime from Drugs, 5/10 . . . . . . . . . . . . 67Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009*Australia Amends Regulations to Include Biologics Framework, 12/10 . . . . . . . . . . . . . . . . 68Proposed Amendments to the Therapeutic Goods Regulations 1990 to Implement theBiologicals Framework*BiosimilarsNICE Suggests First Biosimilar for the UK Market, 6/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Biosimilar Drug Developers Told to Be Patient as US FDA DevelopsRegulatory Framework, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72US FDA Schedules First Public Meeting on Biosimilars Pathway, 10/10. . . . . . . . . . . . . . . 74Approval Pathway for Biosimilar and Interchangeable Biologic Products*

vi FDANEWS GUIDE TO INTERNATIONAL MEDICAL DEVICE REGULATION: 2010 EDITIONEMA Reducing Regulatory Burden for Sponsors of MAb Biosimilars, 12/10 . . . . . . . . . . . 76Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies*Cancer DrugsCanada Ranks Next to Last in Access to Cancer Drugs, Report Prompts Call for CanadianCancer Drug Fund, 8/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Extent and Causes of International Variations in Drug Usage*Analysis: Cancer Drugs Face Most Difficulty Gaining Approval from NICE, 9/10 . . . . . . . 82EMA May Revise Guidance on Cancer Drug Trials to Harmonizewith Recent Appendices, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Concept Paper on the Need to Revise the Guideline on the Evaluation of AnticancerMedicinal Products in Man*Clinical TrialsEMEA Outlines Requirements for GERD Drug Studies, 1/10. . . . . . . . . . . . . . . . . . . . . . . . 87Draft Guideline on the Evaluation of Drugs for the Treatment of Gastroesophageal RefluxDisease*US May Require Subject Consent to Clinical Trial Listings, 1/10. . . . . . . . . . . . . . . . . . . . . 88Informed Consent Elements*EMEA Adopts Clinical Trial Guidelines for Drugs to Treat Epileptic Disorders, 2/10 . . . . 89Guideline on Clinical Investigation of Medicinal Products in the Treatment ofEpileptic Disorders*Osteoarthritis Drug Development Is Focus of EMEA Guidance, 2/10 . . . . . . . . . . . . . . . . . 90US FDA Issues Draft Guidance on Noninferiority Studies, 3/10. . . . . . . . . . . . . . . . . . . . . . 91Guidance for Industry – Non-Inferiority Clinical Trials*FDA Draft Guidance Recommends PK Studies for Some Patients, 4/10 . . . . . . . . . . . . . . . 93Guidance for Industry – Pharmacokinetics in Patients with Impaired Renal Function —Study Design, Data Analysis and Impact on Dosing and Labeling*EU Outlines Process for Submitting Results-Related Data to EudraCT, 6/10 . . . . . . . . . . . . 94Implementing Technical Guidance – List of Fields for Results-Related Information to BeSubmitted to the ‘EudraCT’ Clinical Trial Database*NIH Rule Sets Lower Threshold for Disclosure Requirements, 6/10 . . . . . . . . . . . . . . . . . . 95Responsibility of Applicants for Promoting Objectivity in Research for Which PublicHealth Service Funding is Sought and Responsible Prospective Contractors*US FDA: IND Optional for Foreign Sites Included in Multicountry Study, 6/10 . . . . . . . . . 97Information Sheet Guidance for Sponsors, Clinical Investigators and IRBs: FrequentlyAsked Questions—Statement of Investigator (Form FDA 1572)*US FDA Proposes to Extend Investigator Disqualification Agencywide, 6/10 . . . . . . . . . . . 98Guidance for Institutional Review Boards, Clinical Investigators and Sponsors – ClinicalInvestigator Administrative Actions—Disqualification*

Table of Contents v i iChina’s SFDA Clinical Trial Approvals Process Requires Translation, Attention toRequirements, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99International Drug Industry Group Wants All Phase III Results Published, 7/10 . . . . . . . . 101Study: Burdensome Regulation Creates Barrier for Investigators, 7/10. . . . . . . . . . . . . . . . 102US HHS Inspector General Finds Monitoring of Overseas Clinical Trials Lax, 7/10 . . . . . 103Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials*Canadian Regulation, Safety Measures Stifling Clinical Research, Experts Say, 8/10 . . . . 105Challenge of EU Clinical Trials is Navigating Privacy Rules, 8/10. . . . . . . . . . . . . . . . . . . 106EMA Guidance on Electronic Clinical Trial Data Requires Certified CopiesPrior to Transfer, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108European Medicines Agency Guidance on the Use of Electronic Data in Clinical Trials*US FDA Draft Guidance Proposes Asking Trial Subjects QuestionsAbout Suicidality, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110US FDA Guidance on Suicidality Determinations in Clinical Trials*Industry to EMA: Allow Preapproval of NIMPs Used in Clinical Trials, 10/10 . . . . . . . . . 112Sponsors Should Identify Methods to Avoid Missing Data in Trials, 10/10 . . . . . . . . . . . . 113European Medicines Agency Guideline on Missing Data in Clinical Trials*US Government Apologizes for Intentionally Infecting Guatemalans in 1940s STDStudy, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114EMA Guidance Addresses Individual Case Safety Reports for Clinical Trials, 11/10 . . . . 116Guidance – EudraVigilance Human: Processing of Safety Measures and IndividualCase Safety Reports (ICSRs)*Implementation Plan – EudraVigilance Human: Processing of Safety Messages andIndividual Case Safety Reports (ICSRs)*US FDA Draft Guidance Offers Exceptions for Clinical Trials, 11/10 . . . . . . . . . . . . . . . . 117Guidance for Industry – Investigational New Drug Applications (NDAs) —Determining Whether Human Research Studies Can Be Conducted Without an IND*ENCePP Compiles Guide of International Standards for Clinical Study Design, 12/10 . . . 118ENCePP Guide on Methodological Standards in Pharmacoepidemiology*Checklist of Methodological Research Standards for ENCePP Studies*Codependent TechnologiesAustralia Releases Consultation Regarding Appraisalsof Codependent Technologies, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Draft Information Requests for Assessing a Pair of Co-Dependent Technologies*Compassionate UseEMEA Grants First Early Approval Under Compassionate Use Program, 2/10 . . . . . . . . . 127

viii FDANEWS GUIDE TO INTERNATIONAL PHARMA REGULATION: 2011 EDITIONCompulsory LicensingIndia Considering Compulsory Licensing for Drugs, Seeking Input on Improving DrugAvailability, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Confidential Information ExchangeEMA: ‘Lite’ Confidentiality Pacts Could Reduce Industry Burden, 4/10 . . . . . . . . . . . . . . 135Brazil, China Strengthen Ties on Healthcare Regulation, 6/10 . . . . . . . . . . . . . . . . . . . . . . 136US FDA, CMS Will Protect Trade Secrets Under Information-Sharing MOU, 8/10 . . . . . 137Memorandum of Understanding Between United States Food and Drug Administration andCenters for Medicare & Medicaid Services*EMA, US FDA Agree to Extend Indefinitely Confidential InformationAgreement, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Statement of Authority and Confidentiality Commitment from the European MedicinesAgency Not to Publicly Disclose Non-Public Information Shared by the United StatesFood and Drug Administration*Conflict of InterestIndia Strengthens Ethics Regulations for Drugmakers, Physicians, 1/10. . . . . . . . . . . . . . . 143EMA Adopts Risk-Based Policy for Scientists’ Conflict of Interest, 11/10 . . . . . . . . . . . . 144European Medicines Agency Policy on Conflict of Interest*Corrupt PracticeUS Authorities Investigate Foreign Activities of Big Pharmafor Corrupt Practices, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Australian Trade Group Fines Drugmakers for Misleading Claims,Code of Conduct Breach, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Medicines Australia Code of Conduct Quarterly Report July-September 2010*Counterfeit Medical ProductsTo Protect Against Counterfeits, Industry Should Watch Internet, 3/10 . . . . . . . . . . . . . . . 153US FDA, WHO to Develop Surveillance and Monitoring System to StopCounterfeits, 10/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155International Sting Nets 2.6 Million in Online Counterfeit Drugs, 11/10 . . . . . . . . . . . . . 156US Lawmakers Voice New Concerns Over Anti-CounterfeitingTrade Agreement, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158Diabetes DrugsEMEA Advises Diabetes Trial Sponsors to Review Cardiovascular Risk, 2/10 . . . . . . . . . 161Guideline on Clinical Investigation of Medicinal Products in the Treatment of DiabetesMellitus*US FDA to Combine Two Diabetes Drug Development Guidances, 11/10 . . . . . . . . . . . . 162

Table of Contents i xDrug DevelopmentUS FDA Seeks Sponsor Comment on Drug Co-Development, 6/10 . . . . . . . . . . . . . . . . . . 165Investigational New Drug Applications: Co-Development of Investigational Drugs*Canada Reports Decline in Drug R&D Spending, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166Patented Medicines Pricing Review Board Annual Report 2009US FDA Draft Guidance Explains New Drug Development Tools, 11/10 . . . . . . . . . . . . . 168Guidance for Industry – Qualification Process for Drug Development Tools*Electronic SubmissionsEMA Asks Drugmakers to Use eSubmissions for Parallel Distribution Notices, 9/10 . . . . 171Guideline for the Specifications of e-Submissions of Parallel Distribution NotificationDocuments*Guidance on the Centrally Authorised Products Requiring a Notification of a Change forUpdate of Annexes*Emerging MarketsRegulatory Barriers Accompany Emerging Markets Growth, 4/10 . . . . . . . . . . . . . . . . . . . 175IMS: Global Drug Sales Will Rise in 2011, Driven by Emerging Markets, 10/10 . . . . . . . 176Chinese, US Trade Associations Sign Cooperative Framework, 12/10 . . . . . . . . . . . . . . . . 177EnforcementMHRA Expands Enforcement Toolkit for Pharmaceutical, Device Companies, 7/10 . . . . 181US OIG Has Authority to Exclude Biopharma Officers, Managementfrom Medicare, 11/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Guidance for Implementing Permissive Exclusion Authority Under Section 1128(b)(15) ofthe Social Security Act*Fair TradeUN: Colombia Fair Trade Pact Would Limit Drug Access, 6/10. . . . . . . . . . . . . . . . . . . . . 187EU-South Korea Trade Pact Will Increase Access to Drugs, 10/10. . . . . . . . . . . . . . . . . . . 188FeesEMEA Changes Fees for Variations to Marketing Authorizations, 1/10 . . . . . . . . . . . . . . . 191EMEA Explanatory Note on Marketing Authorization Fee*Canada Proposes Higher User Fees to Help Cover Increased Workload, 5/10 . . . . . . . . . . 192Fixed Dose CombinationsIndia Launches Consultation on Fixed-Dose CombinationsIncluding Investigational Drugs, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Guidance for Industry on Fixed-Dose Combinations (FDC)*

x FDANEWS GUIDE TO INTERNATIONAL PHARMA REGULATION: 2011 EDITIONGeneric DrugsEC Further Expands Investigation into Market Delays of Generics, 1/10 . . . . . . . . . . . . . . 199Generic Sponsor CRO Oversight to Be Tested by EMA Program, 3/10 . . . . . . . . . . . . . . . 200All Canada Watching Ontario’s Plan to Reform Generic Drug System, 5/10 . . . . . . . . . . . 201Brazil, India Gain Headway in Defense of Generics, 6/10. . . . . . . . . . . . . . . . . . . . . . . . . . 203Ontario Approves Generic Drug Price-Slashing Scheme, 6/10 . . . . . . . . . . . . . . . . . . . . . . 205British Columbia Outlines Plan to Lower Generic Drug Prices, 7/10 . . . . . . . . . . . . . . . . . 206UK Drops Plans for Generic Substitution of Primary Care Drugsby Pharmacists, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208Good Manufacturing PracticeTGA Gives Drugmakers Guidance on Nonsterile Drug Supply Chain, 3/10. . . . . . . . . . . . 213Technical Guidance on the Interpretation of Manufacturing Standards: Supplier Qualification*Technical Guidance on the Interpretation of Manufacturing Standards: Process Validationfor Listed Complementary Medicines*New Drug Manufacturing Principles Go into Effect in Australia, 7/10 . . . . . . . . . . . . . . . . 214Manufacturers Sought for Joint US FDA, EMA GMP Inspection Pilot, 8/10 . . . . . . . . . . . 215EMA/FDA Joint GMP Inspection Pilot Program: General Principles*EMA/FDA Joint GMP Inspection Pilot Program: Terms of Reference and Procedures forParticipating Authorities (Manufacturers of Medicinal Products)*China Aligns Drug GMP with Global Standards, US FDA, DrugmakersApplaud Move, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217EC Updates GMP Guide to Include Outsourced Activities for Drugs, 12/10 . . . . . . . . . . . 218Good Manufacturing Practice Chapter 7: Outsourced Activities*US FDA Revising GMP Regulations to Req

FDAnews Guide to International Pharma Regulation: 2011 Edition Table of Contents Appendices are not

Related Documents:

viii FDANEWS GUIDE TO INTERNATIONAL PHARMA REGULATION: 2010 EDITION Direct-to-Consumer Communication MHRA Seeks Comments on EC Proposal to Expand Prescribing Information, 6/09 . . . . . 151 Consultation on Eur

Smart Pharma Consulting. 1, rue Houdart de Lamotte - 75015 Paris - France Tel.: 33 6 11 96 33 78 E-mail: jmpeny@smart-pharma.com Website: www.smart-pharma.com. Consulting company dedicated to Strategy, Management and Organization services in the pharmaceutical sector. Smart Pharma Consulting. Core capabilities. 1. Strategy

N4 Pharma Plc Nigel Theobald, CEO Via Scott PR Allenby Capital Limited James Reeve/Asha Chotai Tel: 44 (0)203 328 5656 Scott PR Georgia Smith Tel: 44 (0)1477 539 539 About N4 Pharma N4 Pharma is a specialist pharma

Goerlich Pharma International GmbH Am Gewerbering 4/6 83533 Edling / Germany Tel.: 49-(0)8071-9083-0 Fax: 49-(0)8071-9083-29 e-Mail: sales@goerlich-pharma.com www.goerlich-pharma.com ARCO // COMPANY 1959 Gründung der A.R.C.O. -Chemie GmbH durch Arthur Loose und Cornelius Souv

Fourth in the Pharma 2020 series and published in April 2009, this report highlights how Pharma’s fully integrated business models may not be the best option for the pharma industry in 2020; more creative collaboration models may be more attractive. This paper also evaluates the

Dow Corning 5 Simethicone and Emulsion 5 . 12.500 cSt Zinc Oxide Pharma 4 API Zinc Oxide Pharma 6 API Zinc Oxide Pharma 8 API . Q7-9120 Silicone Fluid 20 cSt 100 cSt 350 cSt 1.000 cSt 12.500 cSt ST-Dimethiconol 40 Q7-9180 Silicone Fluid 0,65 cSt 1 cSt ST-Cyclomethicone 5-NF ST-Cyclomethicone 56-NF

McKinsey & Company report that 66% of pharma product launches between 2003 and 2009 performed below forecast4. However, pharma is not the only industry facing increasing launch challenges. Consumer product launches experience many hurdles also common to pharma. A 2014 global study by Simon Kucher & Partners revealed that, across all major

hubungan antara asupan asam folat dengan kadar Hb dengan nilai p 0,64. Kata Kunci : asupan fe, asupan folat, kadar hb, tb paru . Abstract . Tuberculosis pulmonary can lead to various metabolic disorders and system disturbances in the body, one of which is synthetic disorder of Hemoglobin levels. Some nutrients which can influence the synthetic of Hemoglobin levels are iron (Fe) and folic .