• Regulatory NewsRegulatory News

    FDA Warns German Contract Manufacturer Over API Stability Concerns

    The US Food and Drug Administration (FDA) has warned Baesweiler, Germany-based contract manufacturer BBT Biotech GMBH over deviations from good manufacturing practices (GMPs), including the failure to provide stability data to support expiration dates for active pharmaceutical ingredients (APIs). The warning letter, sent 16 May and released Tuesday, follows an inspection at the API manufacturing facility in May 2015 during which FDA inspectors found BBT Biotech did not p...
  • Regulatory NewsRegulatory News

    India’s CDSCO Reduces API Stability Testing Data Requirement

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. India’s Central Drugs Standard Control Organization (CDSCO) issued a  notice  on 22 October 2014 cutting the long term stability testing data requirement for active pharmaceutical ingredient (API) exports to the EU from 12 months to 6 months based on results from three ba...
  • FDA Goes into Detail About Generic Drug Stability Testing

    A new guidance document released by the US Food and Drug Administration (FDA) aims to answer some common questions regarding stability testing used to support generic drug applications. Background The guidance, ANDAs: Stability Testing of Drug Substances and Products: Questions and Answers , is a follow-up to a draft guidance released in September 2012 , and then finalized in June 2013 . The stability studies are intended to ensure that a product maintains its pot...
  • FDA Clarifies Stability Testing Requirements for Generics with New Draft Guidance

    The US Food and Drug Administration (FDA) has released a new draft guidance meant to clarify the agency's expectations about abbreviated new drug applications (ANDAs) and the stability testing used to support those applications. Background Under the 1984 Hatch Waxman Act , drug manufacturers were given the ability to compete with innovative drug applications originally filed through the new drug application (NDA) approval pathway. Under the act, innovative products wer...
  • US Throws Out 1995 Standard for Generics Stability Testing, Adopts ICH Standards for NDAs Instead

    The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) as an abbreviated new drug application (ANDA) or a drug master file (DMF). The June 2013 guidance document, ANDAs: Stability Testing of Drug Substances and Products , explains that, "Over the past few years, the Office of Gener...
  • New Draft Stability Guidance Calls for Use of ICH Standards

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH). Abbreviated New Drug Applications (ANDAs) are commonly used to support generic drug applications under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . FDA said it ...
  • European Commission Launches Prize Fund to Encourage Vaccine Temperature Stability

    The European Commission (EC) has launched a €2 million prize in the hopes that the incentive will drive inventors to develop vaccines that can be shipped and stored regardless of the temperature in which they are held. The prize, announced by EC's Commissioner for Research, Innovation and Science Máire Geoghegan-Quinn, should be of particular benefit to those patients in developing countries where cold-chain logistics networks are not established or unreliabl...
  • New FDA Guidance on Evaluation of Veterinary Stability Data

    A new draft guidance for industry out of the US Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) aims to implement the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products' (VICH) GL51 quality measure. The draft guidance, Statistical Evaluation Of Stability Data (VICH GL51) , was released 4 April and deals with Step 4 of VICH's 9-step procedure . "This draft guidance is intended...
  • India Releases Draft Guidance on Clinical Trial Requirements for Stability Data

    On 21 December India's Central Drugs Standard Control Organization (CDSCO) released a new draft guidance titled, Requirement of Chemical & Pharmaceutical Information Including Stability Study Data Before Approval of Clinical Trials / BE Studies . The draft guidance clarifies the CDSCO's thinking regarding rules 122A, B, D, DA, DAA, and E of the Drugs and Cosmetics Rules, and Appendix I, IA and VI of Schedule Y.  These rules govern the information and data nec...