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  • Regulatory NewsRegulatory News

    UK Alerts to Teva Recall of Heartburn Medicines Over Impurity Fears

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday alerted to a recall of its heartburn medicine ranitidine following similar recalls due to possible contamination with an impurity called NDMA (N-nitrosodimethylamine), which may increase the risk of cancer. For health professionals, the MHRA says to stop supplying the products immediately and quarantine all remaining stock and return it to suppliers. Andrew Gray, MHRA deputy director of...
  • Regulatory NewsRegulatory News

    Industry Seeks Clarity on CGT Draft Guidance

    Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...
  • Regulatory NewsRegulatory News

    Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates

    Industry groups PhRMA and the Association for Accessible Medicines (AAM), as well as companies Pfizer and Teva Pharmaceuticals are calling on the US Food and Drug Administration (FDA) to tweak and clarify recently drafted guidance on marketing status updates. The draft guidance from January helps sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they have to share with FDA on the marketing status of thei...
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    FDA Warns Teva Subsidiary Over Quality Failures, CGMP Violations

    Teva Pharmaceuticals subsidiary Actavis Laboratories FL, Inc. received a warning letter last month from the US Food and Drug Administration (FDA) for quality unit concerns and inconsistencies with its laser-drilled tablet manufacturing processes, among other violations. Actavis Laboratories’ quality unit at the Davie, Florida-based site was found to have “failed to fulfill its duties and responsibilities,” the warning letter says, noting for example that the unit did no...
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    Formal Meetings Between FDA and ANDA Applicants: Stakeholders Weigh Draft Guidance

    Drugmakers Sanofi and Teva, alongside industry groups AAM and the Bulk Pharmaceuticals Task Force, offered their comments earlier this month on new draft guidance related to formal meetings between FDA and abbreviated new drug application (ANDA) sponsors. The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force expressed disappointment that, although it participated in the Generic Drug User Fee Amendments (GDUFA II) negotiation...
  • Regulatory NewsRegulatory News

    Updated: Copaxone Generics: Who Will Win First Filer Exclusivity?

    Generic versions of Teva's multi-billion-dollar per year multiple sclerosis drug Copaxone (glatiramer) have arrived, but a closer look at which competitor might win the coveted 180-day exclusivity reveals an unusual and complex situation. Back in January, a US District Court for the District of Delaware ruling invalidated all asserted claims  on Teva's patents on its 40 mg version of Copaxone, opening the door for generic competitors. Late Tuesday, Mylan  announce...
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    Congressmen Investigate 'Shadow Pricing' of MS Drugs

    Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS). Cummings and Welch cited an  American Academy of Neurology study  finding that some companies appear to be increasing their prices when competitors do the same, a practice known as "shadow pricing." The study reported that annual MS drug sale...
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    FDA Approves First Generic Version of Gilead's HIV Drug Truvada

    The US Food and Drug Administration (FDA) on Friday announced it has approved Teva Pharmaceuticals' generic version of Gilead's HIV drug Truvada (emtricitabine and tenofovir disoproxil fumarate). However, Teva has not said how much its version of the drug will cost or when it will be available to patients. A Teva representative declined to comment other than to say the company had received approval. Truvada and HIV PrEP Truvada was initially approved by FDA in 2004 to ...
  • Regulatory NewsRegulatory News

    FDA Warns Teva API Plant in China

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 10 April to Teva for deficiencies related to an active pharmaceutical ingredient (API) manufacturing site in Hangzhou, China. The letter, first disclosed in an SEC filing in which the company said it would respond by 1 May, includes two observations for failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause v...
  • Regulatory NewsRegulatory News

    Multiple Endpoints in Clinical Trials: Biopharma Companies Seek More From FDA Draft Guidance

    Biopharmaceutical heavyweights – from Novartis to GlaxoSmithKline to Regeneron – are seeking additional clarification from the US Food and Drug Administration (FDA) on draft guidance on multiple endpoints in clinical trials, according to comments posted to the docket on Thursday. Background On 12 January, FDA issued a 54-page draft guidance to provide sponsors and review staff with the agency’s thinking on the problems posed by multiple endpoints in the analysis and i...
  • Regulatory NewsRegulatory News

    FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate. The warning letter and deficiencies cited by FDA have major ramifications beyond Pfizer too. The letter has delayed the marketing of Momenta’s generic version of Teva’s blockbuster multiple sclerosis ...
  • Regulatory NewsRegulatory News

    Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals

    The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program. The finalization of the rule, first proposed in 2010, follows fierce criticism of the plan from industry groups PhRMA, BIO and companies including Bayer and Teva. The final rule calls on drug companies to: calculate the 340B ceiling price on a quarterly...