On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly Information sheet on the FTP.
Last week, FDA announced via a blog post simplifications and clarifications to its expanded access program. Under FDA’s expanded access program, physicians may request that patients with a serious condition receive treatment with an investigational product when there is no therapeutic alternative. In particular, FDA made three announcements: FDA has decided that physicians requesting individual patient
On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use.
The European Commission updated Good Manufacturing Practice requirements for medicinal products.
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance on maintaining meeting minutes for Institutional Review Boards (IRBs).
FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D. stated, “Tools like [FAERS] are critical to the FDA’s ability to help ensure the greatest level of transparency and help patients and
The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities. Background information On 17 July 2017, Emily O’Reilly, the European Ombudsman, decided to conduct a strategic inquiry concerning EMA’s arrangements with individual medicinal products developers prior to the submission by these developers of
On the same day that FDA’s Commissioner, Dr. Scott Gottlieb, announced new policy initiatives regarding stem cell therapies and regenerative medicine, FDA announced stepped up enforcement in this area and posted a warning letter issued to U.S. Stem Cell Clinic located in Sunrise, FL. FDA issued the warning letter following an inspection beginning in April
The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement decision was announced against a government entity, a local health commission, for breaching a number of provisions in the Anti-Monopoly Law (AML).
The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to centrally authorised medicinal products. Market Authorisation Holders (MAHs) may need to fulfil post-authorisation measures by providing additional data on safety, efficacy and quality
The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several questions which applicants requesting a scientific opinion as provided in Article 58 of Regulation (EC) No 726/2004 (“Article 58”, the “EMA Regulation”) may have. Article 58
Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777, Enforcing the Regulatory Reform Agenda. On September 8, 2017, FDA published several notices in the Federal Register, to implement these orders, soliciting comments from the
The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides clarification with respect to Section 5 of ICH guideline Q11 on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). This Section
On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate the implementation of the EU Falsified Medicines legislation.
Yesterday, on August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that contain product claims. These types of ads must include, among other things, what is often called a “major statement,” i.e., information relating to the advertised drug’s “major side effects and contraindications” in either the audio or the audio and visual parts of the ad. 21 CFR 202.1(e)(1).
In the FR notice, the agency explained that it is considering a new approach to satisfy this requirement called a “limited risks plus disclosure strategy.” Under this approach, the major statement would be limited to 1) “severe (life-threatening), serious, or actionable” risks and 2) a disclosure to alert consumers that there are other risks not included in the ad. The Federal Register notice elaborated on the definitions of “serious” and “actionable” risks.
The European Medicines Agency (“EMA”) has released a procedural guideline for rapporteurs and coordinators participating in Multinational Assessment Teams (“MNAT”). Background The MNAT initiative provides the option for the EMA scientific committees, including the EMA Committee for Medicinal Products for Human Use (“CHMP”) and the EMA Committee for Advanced Therapies (“CAT”), to rely on assessment
The European Medicines Agency (EMA) has adopted a new guideline on manufacture of the finished dosage form of medicinal products for human use (“the new Guideline”). Background The new guideline replaces the 1996 “Note for Guidance on Manufacture of the Finished Dosage Form” (CPMP/QWP/486/95) to reflect the requirements laid down in the Directive 2001/83/EC of
The European Medicines Agency (“EMA”) has proposed a new draft guideline document on good pharmacovigilance practices concerning medicinal products used by the paediatric population. The proposed guideline will replace the existing “guideline on the conduct of pharmacovigilance for medicines used by the paediatric population” and be a chapter of the good pharmacovigilance practice guidelines (GVP).
The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire, and it was initially open until the end of August 2017. Upon the request of various stakeholders, the European Commission has recently decided to keep
The European Medicines Agency (“EMA”) has sought to support Small and Medium-sized Enterprises (SMEs). As part of this effort, the EMA has launched a new Action Plan to address the challenges that confront SMEs and their stakeholders. In particular the Action plan addressed challenges to SMEs regarding the funding and cost related to regulatory actions.
On July 25, 2017, FDA issued a guidance document implementing a policy which allows IRBs to waive general informed consent requirements for minimal risk studies, similar to the waivers allowed under the Common Rule.
European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press