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  • Regulatory NewsRegulatory News

    FDA’s New Opioid Packaging Plan is Meant to Limit Overprescribing

    As opioid-related overdoses killed almost 50,000 Americans in 2017, the US Food and Drug Administration (FDA) on Thursday began soliciting comments on a plan to require special packaging for certain types of opioids that might be overprescribed. According to research cited by FDA, most patients use significantly fewer pills than they are prescribed after many common less-invasive surgical procedures as well as some common acute pain conditions treated in the primary car...
  • Regulatory NewsRegulatory News

    Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements

    Boehringer Ingelheim has questions on how new US Food and Drug Administration (FDA) draft guidance on optional child-resistant packaging (CRP) statements will benefit health care professionals and consumers. The draft guidance , released 2 August, offers help for drugmakers looking to use the statements and ensure they are clear, useful, informative and, to the extent possible, consistent in content and format. Boehringer, however, questions "whether thi...
  • Regulatory NewsRegulatory News

    Child-Resistant Packaging Statements in Drug Labels: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday published draft guidance to help ensure child-resistant packaging (CRP) statements in drug labels is clear, useful, informative and, to the extent possible, consistent in content and format. The draft, now open for comments, is meant to assist applicants, manufacturers, packagers and distributors in determining what information should be included to support the CRP statements. Background Child-resistant pack...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Tweaks GMP Inspection Closeout Process (17 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Updates Process for Closeout of On-Site GMP Inspections Australia’s Therapeutic Goods Administration (TGA) has revised its process for handling the closeout of on-site good manufacturing practice (GMP) inspections. The updated process ends the practice of issuing close-out letters to manufacturers, with TGA choosing to communicate its closing messages in an inspection r...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Investigates $88M in Improperly Refrigerated Vaccines (22 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls for Investigation Into Sellers of $88M Worth of Improperly Refrigerated Vaccines The China Food and Drug Administration (CFDA) is pressuring local government officials to probe the sale of RMB 570 million ($88 million) worth of improperly refrigerated vaccines. Police officials think the substandard vaccine ring, which was allegedly run by a mother and daughter t...
  • Regulatory NewsRegulatory News

    Canada Proposes New Drug Enforcement Measures, Including Scheduling

    Canada's Minister of Health Rona Ambrose has just announced a series of amendments to the country's Controlled Drugs and Substances Act (CDSA) intended to curb illegal drug manufacturing and use. Proposed Changes The amendments are part of The Protection of Communities from the Evolving Dangerous Drug Trade Act , which increase the government's ability to police and regulate active substances, both legal and illegal. While the amendments are geared toward combating...
  • Feature ArticlesFeature Articles

    Six Recommendations Regarding Upcoming UDI Compliance Dates

    As 2014 fades into memory, the medical device industry faces the next phases of Unique Device Identification (UDI) implementation for devices marketed in the US. September 2015 is the deadline for UDI labeling implementation and data submissions for Implantable, Life-Supporting and Life-Sustaining (I/LS/LS) devices with the remainder of Class II devices following in 2016. 1 The Class III device UDI compliance date passed on 24 September 2014. Overall, implementation of ...
  • Regulatory NewsRegulatory News

    Massive Recall of Medical Devices Largest Ever Recorded by FDA

    A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA. Background: Recall Trends The devices, which were manufactured by Puerto Rico-based device manufacturer Customed, Inc, were given a Class I recall classification —FDA's most serious recall classification, given to those devices in cases where "there is a reasonable probability t...