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    Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance

    The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ensure data is consistent and accurate. The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records, as well as re...
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    FDA Continues Crackdown on Noncompliant Chinese Pharmaceutical Manufacturers

    Three more Chinese pharmaceutical companies were added to two US Food and Drug Administration (FDA) import alert lists this week for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. On Wednesday, FDA added Xinxiang Pharmaceutical Co. and  Xinxiang Tuoxin Biochemical Co., noting: “Only drug and drug products (i.e. adenosine, choline, uridine, uracil, cytidine, inosine, and all pharmaceutical intermediates) are sub...
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    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...
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    MHRA Takes Action on LinkedIn Pharma Marketing

    The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) on Friday said it has reprimanded the dermatology company Galderma after receiving an anonymous complaint about promotional material for a prescription drug shared on the social networking site LinkedIn. MHRA said it upheld the complaint as the UK, unlike the US, does not allow prescription-only medicines to be promoted to the public though it does allow advertisements for over-the-counter medicines, accor...
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    FDA Warns Sun’s India Plant Over Sterility Concerns

    Serious aseptic and sterility violations, including water damage and leaks in parenteral manufacturing areas, were documented by the US Food and Drug Administration (FDA) in the latest warning letter for Sun Pharmaceutical’s manufacturing plant in Halol, India. Since the September 2014 inspection, FDA has withheld future product approvals from the Halol facility. The company was cited in a separate warning letter in May 2014 for data integrity concerns (trash bags...
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    New Draft Guidance on Best Practices for IND Communications Between Sponsors, FDA

    Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. The communications between FDA and industry are often opportunities to share cirtical information on clinical trials and for the agency to provide advice on trial design, dose selection...
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    Industry Conflicts With FDA: The Options

    Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...
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    FDA Bans Imports From Major Indian API Manufacturer

    The US Food and Drug Administration (FDA) on Wednesday added Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, to a list of foreign manufacturing sites banned from sending products to the US. Megafine, which was hit with an FDA Form 483 back in May at the site, produces 24 APIs for the US market , including for drugs intended to treat Alzheimer's disease, depression, schizophrenia, multiple sclerosis and over...
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    FDA to Study Whether Consumers Can Take More Complicated Info in Pharma TV Ads

    As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads. The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads. T...
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    Landmark EU Court Ruling Ends Uncertainty Over Duration of Biotech Patent Protection

    Pharmaceutical and biotech companies are cheering a ruling issued earlier this week by the Court of Justice of the European Union (CJEU) that essentially adds up to a couple days' worth of patent protection to medicinal products, but could mean millions of Euros for the companies. The ruling is concerned specifically with Supplementary Protection Certificates (SPCs), which extend the duration of certain rights associated with a patent and are typically provided to compe...
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    Asia Regulatory Roundup: Japanese Regulators Receive Orphan Drug Training from EMA (6 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Japanese Regulators Receive Orphan Drug Training from EMA Staffers at Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) have received training on orphan medicines from the European Medicines Agency (EMA). The training session was led by Dr. Segundo Mariz, a member of EMA’s Committee for Orphan Medicinal Products (COMP). Mariz has worked on the committee since ...
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    Indian Manufacturer Seeks Compulsory License for Type II Diabetes Drug Saxagliptin

    An Indian manufacturer has filed the third-ever compulsory license application in India for AstraZeneca's type II diabetes drug saxagliptin, SpicyIP reports. Background Compulsory licensing is a legal provision that allows for the licensing of intellectual property rights without the rights holder's consent. The power to grant these licenses is seen by some countries, especially low- and middle-income ones, as a powerful tool to ensure important drugs are available a...