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    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
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    Hormonal Contraception: FDA Drafts Guidance on Clinical Trial Recommendations

    As hormonal drugs to prevent pregnancy have evolved over the years, the US Food and Drug Administration (FDA) on Thursday drafted new guidance for drug developers on the recommendations for clinical trials designed to establish clinical effectiveness and safety for such products. In terms of key considerations for clinical trial design features, the six-page draft begins by explaining the recommended enrollment criteria for nonpregnant, premenopausal woman in trials, wh...
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    FDA Revises 1999 Draft Guidance on Population Pharmacokinetics

    The US Food and Drug Administration (FDA) on Thursday released revised draft guidance to help keep sponsors informed on the data and model requirements for population pharmacokinetics (PK) analyses submitted as part of new drug applications and biologic license applications. Since the original population PK guidance was published in 1999, FDA says the number of applications relevant for population PK analysis has increased and, “The sophistication and reliability of pop...
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    WHO Lays Out Five-Year Regulatory Action Plan

    As part of efforts to increase access to quality medical products around the globe, the World Health Organization (WHO) this month crafted a five-year plan to promote regulatory collaboration and reliance, and to help national regulatory authorities (NRAs) solve capacity issues and other challenges. According to WHO surveys, only 30% of NRAs in 2018 had the capacity to effectively and efficiently regulate medical products, although there was greater capacity to regulate...
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    New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance on the US Pharmacopoeial Convention Pending Monograph Process (USP-PMP), outlining how sponsors can revise or create new monographs so they are harmonized with a new product’s FDA-approved quality and labeling requirements.   Background   New and generic drug applicants and drug master file holders must ensure that a drug product or substance complies with applicable standards in the US...
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    FDA Warns Akorn for Repeat Violations

    Following a more than one-month inspection last summer, the US Food and Drug Administration (FDA) on Tuesday released a warning letter for Akorn’s Somerset, New Jersey manufacturing facility due to cGMP violations. The warning letter, issued 13 June and discussed by Akorn on 25 June, echoes some of the observations made by FDA in a Form 483 for the site last November. FDA specifically raises concerns with the site’s quality system, which “does not adequately ensu...
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    Manufacturing Concerns Lead FDA to Pull 31 Apotex ANDAs

    The US Food and Drug Administration (FDA) on Tuesday said it is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after manufacturing deficiencies were found at two of the company’s plants. The FDA action follows Apotex’s initial request to withdraw the ANDAs in January 2018. FDA said it became aware of concerns involving material manufactured at the two Apotex facilities, at least one of which was named in each of the pulled ANDAs....
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    Judge Blocks Pharma Prices in TV Ads Rule From Taking Effect

    US District Court Judge Amit Mehta late Monday ruled that the US Department of Health and Human Services (HHS) lacks the authority to require drugmakers to post list prices in pharmaceutical direct-to-consumer (DTC) television advertisements. The HHS rule, which was set to take effect on Tuesday and finalized in May , called for television advertisements for prescription drugs with a list price of $35 or more to contain a statement indicating the Wholesale Acquisition ...
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    Spanish Regulator Revokes GMP Certificate of Generic Drugmaker

    The Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) last month issued a statement of noncompliance with Good Manufacturing Practice (GMP) and revoked the GMP certificate of Barcelona-based generic drugmaker Novocat Farma. Following a 4 June inspection, the statement of noncompliance, issued 27 June, said the site does not have a technical director or substitute technical director. “During the period when the technical director was on sick leave, there...
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    FDA to Speed Review of Generic Versions of Opioid Overdose Antidote

    The US Food and Drug Administration (FDA) on Monday said it would prioritize and expedite the review of generic versions of drugs indicated for the emergency treatment of opioid overdoses. The decision follows FDA’s approval in April of the first generic of the life-saving naloxone nasal spray, commonly known as Narcan. Under the “Public Health Emergency” prioritization factor in MAPP 5240.3 , FDA says it will expedite the review of all abbreviated new drug applic...
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    EC Explains Brexit’s Impact on GLP

    Beginning 1 November, the UK will likely not be a member of the EU. As that date approaches, the European Commission has outlined the consequences of how EU rules in the field of Good Laboratory Practice (GLP) will no longer apply to the UK, although an EU-wide “Mutual Acceptance of Data” (MAD) system will apply. The MAD system, established under the Organisation for Economic Co-operation and Development (OECD), will apply as of the UK’s withdrawal date, and all member ...
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    Epidermolysis Bullosa: FDA Seeks to Help Development of New Treatments

    The US Food and Drug Administration (FDA) recently released guidance to help companies develop new treatments for epidermolysis bullosa (EB), which is a debilitating and often fatal rare disease. The six-page draft guidance offers details on considerations for clinical trial design, including trial population (estimates suggest 25,000-50,000 people in the US have EB), discussion of efficacy endpoints (i.e. effects on patients’ signs or symptoms such as itching, pain, bl...