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  • Regulatory NewsRegulatory News

    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India’s DCGI Asks Industry How to Further Cut Regulatory Burdens (5 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. DCGI Asks Industry How to Further Cut Regulatory Burdens DCGI Dr. GN Singh has asked the industry how his agency can further reduce the regulatory burden companies face. Singh put out the call for suggestions about how DCGI can streamline drug regulation as part of a release detailing the changes it has already made to make it easier to do business in India. The ind...
  • Regulatory NewsRegulatory News

    New Maryland Law to Restrict Generic Drug Price Increases

    A new Maryland law to keep generic drug prices from increasing by too much goes a step further than price transparency bills and laws in other states, but it’s leaving some with more questions about its broader impact. Just before the weekend, Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill, HB 631 , to become law, though he did not sign the bill and expressed reservations about "unintended consequences." In a letter to the Maryland Spea...
  • Regulatory NewsRegulatory News

    FDA to Texas and Arizona: Destroy or Export Detained Shipments of Execution Drugs

    After a lengthy wait, the US Food and Drug Administration (FDA) has officially told Texas and Arizona that their imported execution drugs cannot be used because they were unlawfully obtained. FDA spokesperson Lyndsay Meyer told Focus via email: “The FDA has notified the Texas Department of Criminal Justice and the Arizona Department of Corrections that their detained shipments of sodium thiopental have been refused on the basis that the detained drugs appear to be...
  • Feature ArticlesFeature Articles

    Debarred, Denied, Restricted? Legal Responsibilities in Outsourcing

    • 29 April 2014
    • By
    Regulatory professionals frequently work with their supply chain colleagues to ensure all relevant documentation is provided for the export of goods from the country of origin. However, there are little-known US regulatory requirements with potentially significant administrative and criminal consequences for violation, and many manufacturers may not be aware of them. The US Departments of Commerce, State and the Treasury publish lists of US and international individuals a...
  • FDA to Potentially Expand State-Administered Device Inspection Program

    The US Food and Drug Administration (FDA) is preparing to potentially expand a rarely used program intended to help the agency conduct inspections of medical device manufacturers. Background The program, known as the Medical Device Inspection Program (MDIP), allows manufacturers of low-risk (Class I and II) medical devices to be inspected for compliance with good manufacturing practices (GMPs) by state-not federal-regulators. Per Section 510(h) of the Federal Food, Dr...
  • China: SFDA Issues New Draft Excipient Rules

    China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production. Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the...
  • China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds

    The Chinese State Food and Drug Administration (SFDA) issued a Notice to Provinces, Autonomous Regions, and Municipalities on 16 May revising the instructions in the Chinese non-prescription drugs (OTC) manual related to the pediatric use requirements for amantadine hydrochloride compounds.  The compounds can no longer be used in newborns and children under one year of age due to a lack of safety and effectiveness data and are not recommended for children under th...
  • China: Deadlines Established For Opthalmic GMP Implementation

    The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...
  • New Head of Chinese Regulatory Agency Appointed

    The Central Committee of the Communist Party of China (CCCPC) appointed a new head of the State Food and Drug Administration (SFDA) on 21 February. Yin Lin, MD  was formerly a visiting scholar at the Harvard School of Public Health from 2003-4, the Chief of Staff for the Ministry of Health and served on the World Health Organization Executive Board Committee. Yin Li will now serve as Commissioner of SFDA and a Party Secretary. Read more: Yin Li appointed a...
  • Obama, Largely Silent on Healthcare in State of the Union Speech, Takes Shot at Medical Device Failures

    Last night's State of the Union (SOTU) Speech devoted just 44 words of a 6,957-word speech to healthcare-a striking departure from prior speeches that highlighted the Obama administration's actions on the Patient Protection and Affordable Care Act (PPACA). However, regulations-including medical device regulation-received some attention in the President's speech. In the middle of his SOTU speech, Obama turned to critics of his administration's regulatory policies, and...
  • China Releases New Standards on Registration of Drug Substances Containing Mixed Powder

    China's State Food and Drug Administration (SFDA) today released new standards on the registration of drug substances containing mixed powders. The new notice is intended to standardize and clarify relevant requirements of "drug substances mixed powder" used in the preparation of pharmaceutical products. SFDA noted that this new standard should promote a higher level of product quality amongst products containing the mixed powders. SFDA - SFDA further standardizes ...