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Category Archives: Pharmaceutical & Biotechnology

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With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status

Poland: New Medical Research Agency

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices. It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom

Poland: Post-registration changes required in case of no-deal Brexit

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit. In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration

FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle Pharmaceuticals, Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C.) (Jun. 8, 2018).  At issue following the Eagle decision was whether the exclusivity

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers
On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report”). The Report summarizes the impressive enforcement activity of EU competition law enforcers in the pharmaceutical sector in the last decade while emphasizing at the same time the scope for continued enforcement action.

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market.  Although the draft guidance doesn’t break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply. Citing

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients and providers, and (perhaps in particular) generic drug developers.  The Commissioner’s announcement addresses several important issues, including patent listing standards

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases

Introduction On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start

Pharma Companies May Benefit from Proposed Patent Law Changes in China; Public Comment Invited

On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs.  A potentially important condition to one of the key proposed changes specific to new drugs is that it would be available only for

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some functions shut down, as was announced yesterday.  Among other things, FDA has furloughed 42% of its employees, according

Effects of Brexit on reimbursement decisions concerning medicinal products in Poland

The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for

EMA publishes draft Guideline on clinical investigation of haemophilia B medicinal products

Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products.

FDA Finalizes Data Integrity Guidance, With Some Noteworthy Changes

Earlier today, FDA published its finalized Data Integrity Guidance.  The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency’s April 2016 Draft Guidance covering the design, operation, and monitoring of systems and controls to maintain data integrity to comply with current good manufacturing practice (cGMP) for

Four new FDA guidances and proposed rule advance biosimilars policy framework

Today, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).  The guidances include a final guidance and a draft Q&A on

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before (see our previous blog posts here and here), significant news broke on December 7, 2018, regarding a newly implemented pilot centralized drug procurement program (the “program”) that will have significant ramifications for global pharmaceutical companies. 

EMA publishes draft guideline on the quality of water for pharmaceutical use

Introduction The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent

The EMA launches a public consultation on eSource Direct Data Capture in clinical trials

The European Medicines Agency (EMA) has published a draft qualification Opinion[1] concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The draft Opinion was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP). It presents CHMP’s views on the “regulatory acceptability” of eSource

EMA launches public consultation on the use of patient disease registries for regulator purposes

Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval inspections.  The protocols were developed through the agency’s New Inspection Protocol Project (the “NIPP”), initially launched in 2014.  The NIPP is intended to

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes the framework under which the DoD and FDA will implement  Public Law 115-92, which was enacted in 2017.  The law gives the DoD new opportunities to advocate to FDA for expedited development,

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical Group, and the founder of both companies, Dr. Bryn Jarald Henderson, based on deceptive stem cell therapy claims.  In its complaint, the FTC alleged Henderson and the companies made unsupported claims, including that “amniotic stem cell